Systems, devices, and methods for bodily fluid sample collection

ABSTRACT

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.

BACKGROUND

A blood sample for use in laboratory testing is often obtained by way ofvenipuncture, which typically involves inserting a hypodermic needleinto a vein on the subject. Blood extracted by the hypodermic needle maybe drawn directly into a syringe or into one or more sealed vials forsubsequent processing. When a venipuncture may be difficult orimpractical such as on a newborn infant, a non-venous puncture such as aheel stick or other alternate site puncture may be used to extract ablood sample for testing. After the blood sample is collected, theextracted sample is typically packaged and transferred to a processingcenter for analysis.

Unfortunately, conventional sample collection and testing techniques ofbodily fluid samples has drawbacks. For instance, except for the mostbasic tests, blood tests that are currently available typically requirea substantially high volume of blood to be extracted from the subject.Because of the high volume of blood, extraction of blood from alternatesample sites on a subject, which may be less painful and/or lessinvasive, are often disfavored as they do not yield the blood volumesneeded for conventional testing methodologies. In some cases, patientapprehension associated with venipuncture may reduce patient compliancewith testing protocol. Furthermore, the traditional collection techniqueadds unnecessary complexity when trying to separate a single bloodsample into different containers for different pre-analyticalprocessing.

SUMMARY

At least some of disadvantages associated with the prior art areovercome by at least some or all of the embodiments described in thisdisclosure. Although the embodiments herein are typically described inthe context of obtaining a blood sample, it should be understood thatthe embodiments herein are not limited to blood samples and can also beadapted to acquire other fluid(s) or bodily sample(s) for analysis.

In one embodiment described herein, a device is provided for collectinga bodily fluid sample. This embodiment may be useful for accuratelycollecting small volumes of bodily fluid sample that are oftenassociated with non-venous blood draws. In one non-limiting example, thesample volume is about 1 mL or less. Optionally, the sample volume isabout 900 uL or less. Optionally, the sample volume is about 800 uL orless. Optionally, the sample volume is about 700 uL or less. Optionally,the sample volume is about 600 uL or less. Optionally, the sample volumeis about 500 uL or less. Optionally, the sample volume is about 400 uLor less. Optionally, the sample volume is about 300 uL or less.Optionally, the sample volume is about 200 uL or less. Optionally, thesample volume is about 100 uL or less. Optionally, the sample volume isabout 90 uL or less. Optionally, the sample volume is about 80 uL orless. Optionally, the sample volume is about 70 uL or less. Optionally,the sample volume is about 60 uL or less. Optionally, the sample volumeis about 50 uL or less.

In one non-limiting example, this device can be used to split the bodilyfluid sample directly into two or more different portions that are thendeposited into their respective containers. In one non-limiting example,the device comprises a first portion having at least two samplecollection channels configured to draw the fluid sample into the samplecollection channels via a first type of motive force, wherein one of thesample collection channels has an interior coating designed to mix withthe fluid sample and another of the sample collection channels hasanother interior coating chemically different from said interiorcoating. The sample collection device includes a second portioncomprising a plurality of sample containers for receiving the bodilyfluid sample collected in the sample collection channels, the samplecontainers operably engagable to be in fluid communication with thecollection channels, whereupon when fluid communication is established,the containers provide a second motive force different from the firstmotive force to move a majority of the bodily fluid sample from thechannels into the containers. The containers may be arranged such thatmixing of the fluid sample between the containers does not occur.Because this device may be used with non-venous draws, it may take alonger period of time to obtain a desired volume of sample and the earlyintroduction of a material such as an anti-coagulant which may coat thechannels, can prevent premature clogging of the channels duringcollection.

In another embodiment described herein, a device is provided forcollecting a bodily fluid sample. The device comprises a first portioncomprising a plurality of sample collection channels, wherein at leasttwo of the channels are configured to simultaneously draw the fluidsample into each of the at least two sample collection channels via afirst type of motive force. The device may also include a second portioncomprising a plurality of sample containers for receiving the bodilyfluid sample collected in the sample collection channels, wherein thesample containers have a first condition where the sample containers arenot in fluid communication with the sample collection channels, and asecond condition where the sample containers are operably engagable tobe in fluid communication with the collection channels, whereupon whenfluid communication is established, the containers provide a secondmotive force different from the first motive force to move bodily fluidsample from the channels into the containers.

In a still further embodiment described herein, a method is providedcomprising metering a minimum amount of sample into at least twochannels by using a sample collection device with at least two of thesample collection channels configured to simultaneously draw the fluidsample into each of the at least two sample collection channels via afirst type of motive force. After a desired amount of sample fluid hasbeen confirmed to be in the collection channels, fluid communication isestablished between the sample collection channels and the samplecontainers, whereupon the containers provide a second motive forcedifferent from the first motive force use to collect the samples to movebodily fluid sample from the channels into the containers. In somealternative embodiments, devices that use only a single channel tocollect the body fluid or devices that have a plurality of channels butdo not collect them simultaneously are not excluded. Optionally, thecollection of sample fluid is performed without the use of a wickingmaterial.

In one embodiment, there is a discrete amount of time between samplecollection and introduction of the sample into a sample pre-processingdevice. In one non-limiting example, the process is a non-continuousprocess. The sample collection occurs in one processing station and thenthe sample is taken to a second station. This second station may be inthe sample building. Optionally, the second station may be located atanother location where the sample needs to be walked, driven, flown,conveyor-ed, placed in a transport device, or placed in a transportcontainer to reach the second location. In this manner, there is adiscrete break in the processing to allow for time associated withsample transport.

In another embodiment herein, separator gel(s) can also be included inthe sample containers such that the gels will separate cell-freefractions of whole blood from the cellular or other solid or semi-solidportions of the sample. Such a gel or other similar separator materialmay be included in the sample container prior to, during, or aftersample has been introduced into the sample container. The separatormaterial may have a density between that of the cells and solutioncomponents, so that the material separates the sample components byflowing to a position between the solution and non-solution samplelayers during separation such as by centrifugation. Followingcentrifugation, the separator material stops flowing and remain as asoft barrier between the layers. In some embodiments, the separatormaterial can be further processed to harden into a more rigid barrier.In on non-limiting example, the separator material may be a UV-curablematerial such as but not limited to thixotropic gel of sorbitol-basedgelator in a diacrylate oligomer. The sample container may have theentire vessel or optionally, on that portion with the UV-curablematerial exposed to UV light for a period of time such as but notlimited to 10 to 30 seconds to harden the material. Such hardening mayinvolve cross-linking of material in the UV-curable material.Optionally, the UV curable material may be used in conjuction withtraditional separator gel material such that only one side (the solutionside or the solid side) is in contact with the UV cured material.Optionally, the UV cured material may be used with a third material suchthat the UV cured material is between two separator materials and is notin direct contact with the solution and non-solution portions of thesample.

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B show perspective views of a sample collection deviceaccording to one embodiment as described herein.

FIGS. 2A-2C show perspective views of a sample collection device withouta cap according to one embodiment as described herein.

FIGS. 3A-3B show side and cross-sectional views of a sample collectiondevice according to one embodiment as described herein.

FIGS. 4A-4B show side and cross-sectional views of a sample collectiondevice according to one embodiment as described herein.

FIGS. 5A-5B show perspective views of a sample collection deviceaccording to another embodiment as described herein.

FIGS. 6A-6B show side views of a sample collection device according toone embodiment as described herein.

FIGS. 7A-8B show side and cross-sectional views of a sample collectiondevice according to one embodiment as described herein.

FIGS. 9A-9C show side cross-sectional views of a sample collectiondevice at various stages of use according to one embodiment as describedherein.

FIGS. 10A-10B show perspective views of a sample collection deviceaccording to one embodiment as described herein.

FIGS. 11A-11R show various views of a sample collection device accordingto one embodiment as described herein.

FIG. 12 shows a schematic of a tip portion of a sleeve and associatedbalance of forces associated with one embodiment as described herein.

FIGS. 13A-15 show various views of a collection device with a singlecollection location according to one embodiment as described herein.

FIGS. 16-17 show perspective and end views of a sample collection deviceusing containers having identifiers according to one embodiment asdescribed herein.

FIGS. 18A-18E show various views of sample containers according toembodiments as described herein.

FIGS. 19A-19C show view of various embodiments of a front end of asample collection device.

FIGS. 20A-21 show various embodiments of sample collection device withan integrated tissue penetrating member.

FIGS. 22A-22C show schematics of various embodiments as describedherein.

FIG. 23 shows a schematic view of one embodiment of system describedherein.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed. It may be notedthat, as used in the specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a material”may include mixtures of materials, reference to “a compound” may includemultiple compounds, and the like. References cited herein are herebyincorporated by reference in their entirety, except to the extent thatthey conflict with teachings explicitly set forth in this specification.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

“Optional” or “optionally” means that the subsequently describedcircumstance may or may not occur, so that the description includesinstances where the circumstance occurs and instances where it does not.For example, if a device optionally contains a feature for a samplecollection well, this means that the sample collection well may or maynot be present, and, thus, the description includes both structureswherein a device possesses the sample collection well and structureswherein sample collection well is not present.

Referring now to FIGS. 1A-1B, one embodiment of a sample collectiondevice 100 will now be described. In this non-limiting example, thesample collection device 100 may include a collection device body 120,support 130, and base 140. In some instances, a cap 110 may beoptionally provided. In one embodiment, the cap may be used to protectthe opening, keeping it clean, and for covering up the bloody tip aftercollection. Optionally or alternatively, the cap may also be used tolimit flow rate during transfer of sample fluid into the samplecontainers by controlling the amount of venting provided to thecapillaries. Some embodiments may include vents pathways (permanentlyopen or operably closable) in the cap while others do not. Optionally,the collection device body 120 can include a first portion of the device100 having one or more collection pathways such as but not limited tocollection channels 122 a, 122 b therein, which may be capable ofreceiving sample B. FIG. 1A shows that sample B only partially fillingthe channels 122 a, 122 b, but it should be understood that, althoughpartial fills are not excluded in some alternative embodiments, in mostembodiments, the channels will be fully filled with sample B when thefill process is completed. In this embodiment, the base 140 may have oneor more fill indicators 142 a, 142 b, such as but not limited to opticalindicators, that may provide an indication of whether sample has reachedone or more container housed in the base. It should be understood thatalthough this indication may be by way of a visual indication, otherindication methods such as audio, vibratory, or other indication methodsmay be used in place of or in combination with the indication method.The indicators may be on at least one of the containers. There may bevariations and alternatives to the embodiments described herein and thatno single embodiment should be construed to encompass the entireinvention.

Although not shown for ease of illustration, the support 130 may alsoinclude one or more fill indicators showing whether a desired fill levelhas been reached in the channels 122 a and 122 b. This may be in placeof or in addition to fill indicators 142 a, 142 b. Of course, the one ormore pathway fill indicators can be positioned on a different part andis not limited to being on support 130. It should be understood thatalthough this indication of fill level in one or more of the channels122 a and 122 b may be by way of a visual indication, other indicationmethods such as audio, vibratory, or other indication methods may beused in place of or in combination with the indication method. Theindicator may be on at least one of the collection pathways. Optionally,indicators are on all of the collection pathways.

In the present embodiment, the support 130 can be used to join the body120 and the base 140 to form an integrated device. It should beunderstood that although the device body 120, support 130, and base 140are recited as separate parts, one or more of those parts may beintegrally formed to simplify manufacturing and such integration is notexcluded herein.

In some embodiments herein, a cap 110 may be optionally provided. In onenon-limiting example, the cap may be fitted over a portion of thecollection device body 120. The cap 110 may be detachable from thecollection device body 120. In some instances, the cap 110 may becompletely separable from the collection device body 120, or may retaina portion that is connected to the collection device body, such as butnot limited to being hinged or otherwise linked to the collectiondevice. The cap 110 may cover a portion of the collection device body120 containing exposed ends of one or more channels therein. The cap 110may prevent material, such as air, fluid, or particulates, from enteringthe channels within the device body, when the cap is in place.Optionally, the cap 110 may attach to the collection body 120 using anytechnique known or later developed in the art. For instance, the cap maybe snap fit, twist on, friction-fit, clamp on, have magnetic portions,tie in, utilize elastic portions, and/or may removably connect to thecollection device body. The cap may form a fluid-tight seal with thecollection device body. The cap may be formed from an opaque,transparent, or translucent material.

In one embodiment, a collection device body 120 of a sample collectiondevice may contain at least a portion of one or more collection pathwayssuch as but not limited to channels 122 a, 122 b therein. It should beunderstood that collection pathways that are not channels are notexcluded. The collection device body may be connected to a support 130that may contain a portion of one or more channels therein. Thecollection device body may be permanently affixed to the support or maybe removable with respect to the support. In some instances, thecollection device body and the support may be formed of a singleintegral piece. Alternatively, the collection device body and supportmay be formed from separate pieces. During the operation of the devicethe collection device and support do not move relative to one another.

Optionally, the collection device body 120 may be formed in whole or inpart from an optically transmissive material. For example, thecollection device body may be formed from a transparent or translucentmaterial. Optionally, only select potions of the body are transparent ortranslucent to visualize the fluid collection channel(s). Optionally,the body comprises an opaque material but an opening and/or a window canbe formed in the body to show fill levels therein. The collection devicebody may enable a user to view the channels 122 a, 122 b within and/orpassing through the device body. The channels may be formed of atransparent or translucent material that may permit a user to seewhether sample B has traveled through the channels. The channels mayhave substantially the same length. In some instances a support 130 maybe formed of an opaque material, a transparent material, or atranslucent material. The support may or may not have the same opticalcharacteristics of the collection device body. The support may be formedfrom a different material as the collection device body, or from thesame material as the collection device body.

The collection device body 120 may have any shape or size. In someexamples, the collection device body may have a circular, elliptical,triangular, quadrilateral (e.g., square, rectangular, trapezoidal),pentagonal, hexagonal, octagonal, or any other cross-sectional shape.The cross-sectional shape may remain the same or may vary along thelength of the collection device body. In some instances, the collectiondevice body may have a cross-sectional area of less than or equal toabout 10 cm², 7 cm², 5 cm², 4 cm², 3 cm², 2.5 cm², 2 cm², 1.5 cm², 1cm², 0.8 cm², 0.5 cm², 0.3 cm², or 0.1 cm². The cross-sectional area mayvary or may remain the same along the length of the collection devicebody 120. The collection device body may have a length of less than orequal to about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm,4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm. The collection device body120 may have a greater or lesser length than the cap, support or base,or an equal length to the cap, support, or base. There may be variationsand alternatives to the embodiments described herein and that no singleembodiment should be construed to encompass the entire invention.

In one embodiment, the collection pathways such as but not limited tochannels 122 a, 122 b may also have a selected cross-sectional shape.Some embodiments of the channels may have the same cross-sectional shapealong the entire length of the channel. Optionally, the cross-sectionalshape may remain the same or may vary along the length. For example,some embodiments may have one shape at one location and a differentshape at one or more different locations along the length of thechannel. Some embodiments may have one channel with one cross-sectionalshape and at least one other channel of a different cross-sectionalshape. By way of non-limiting example, some may have a circular,elliptical, triangular, quadrilateral (e.g., square, rectangular,trapezoidal), pentagonal, hexagonal, octagonal, or any othercross-sectional shape. The cross-sectional shape may be the same for thebody, support, and base, or may vary. Some embodiments may select ashape to maximize volume of liquid that can be held in the channels fora specific channel width and/or height. Some may have one of thechannels 122 a, 122 b with one cross-sectional shape while anotherchannel has a different cross-sectional shape. In one embodiment, thecross-sectional shape of the channel can help maximize volume therein,but optionally, it can also optimize the capillary pulling forces on theblood. This will allow for maximized rate of filling. It should beunderstood that in some embodiments, the cross-sectional shape of thechannel can directly affect the capillary forces. By way of non-limitingexample, a volume of sample can be contained in a shallow but widechannel, or a rounded channel, both containing the same volume, but onemight be desirable over the other for filling speed, less possibility ofair entrapment, or factors related the performance of the channel.

Although the channels may have any shape or size, some embodiments areconfigured such that the channel exhibits a capillary action when incontact with sample fluid. In some instances, the channel may have across-sectional area of less than or equal to about 10 mm², 7 mm², 5mm², 4 mm², 3 mm², 2.5 mm², 2 mm², 1.5 mm², 1 mm², 0.8 mm², 0.5 mm², 0.3mm², or 0.1 mm². The cross-sectional size may remain the same or mayvary along the length. Some embodiments may tailor for greater forcealong a certain length and then less in a different length. Thecross-sectional shape may remain the same or may vary along the length.Some channels are straight in configuration. Some embodiments may havecurved or other shaped path shapes alone or in combination with straightportions. Some may have different orientations within the device body120. For example, when the device is held substantially horizontally,one or more channels may slope downward, slope upward, or not slope atall as it carries fluid away from the initial collection point on thedevice.

The channels 122 a, 122 b may be supported by the device body 120 and/orthe support 130. In some instances, the entire length of the channelsmay be encompassed within the combination of the device body and thesupport. In some instances, a portion of the channels may be within thedevice body and a portion of the channels may be within the support. Theposition of the channels may be affixed by the device body and/or thesupport. In some embodiments, the channels may be defined as lumensinside a hollow needle. In some embodiments, the channels are onlydefined on three sides, with at least one side that is open. Optionally,a cover layer separate from the body may define the side that wouldotherwise be open. Some embodiments may define different sides of thechannel with different materials. These materials can all be provided bythe body or they may be provided by different pieces of the collectiondevice. Some embodiments may have the channels all in the same plane.Optionally, some may have a shape that takes at least a portion of thechannel to a different plane and/or orientation. Optionally, somechannels may be entirely in a different plane and/or orientation.

In some instances, a plurality of channels may be provided. In someembodiments, one channel splits into two or more channels. Optionally,some channels split into an even larger number of channels. Somechannels may include a control mechanism such as but not limited to avalve for directing flow in the channel(s). At least a portion of thechannels may be substantially parallel to one another. Alternatively, noportion of the channels need be parallel to one another. In someinstances, at least a portion of the channels are not parallel to oneanother. Optionally, the channels may be slightly bent. Optionally,channels may have one cross-sectional area at one location and a smallercross-sectional area at a different location along the channel.Optionally, channels may have one cross-sectional area at one locationand a larger cross-sectional area at a different location along thechannel. For some embodiments of the Y design, it may be desirable thatthe channels would have vents placed appropriately to define the samplefor each vial such that there would not be sample pulled or crosscontamination from other channels. By way of non-limiting example, oneembodiment with vents is shown in FIG. 11I.

A base 140 may be provided within the sample collection device. The basemay be connected to the support 130. In some instances, a portion of thebase may insertable within the support and/or a portion of the supportmay be insertable within the base. The base may be capable of movingrelative to the support. In some instances, a sample collection devicemay have a longitudinal axis extending along the length of the samplecollection device. The base and/or support may move relative to oneanother in the direction of the longitudinal axis. The base and/orsupport may be capable of moving a limited distance relative to oneanother. Alternatively, the base may be fixed relative to the support.The base may be provided at an end of the sample collection deviceopposite an end of the sample collection device comprising a cap 110.Optionally, some embodiments may include an integrated base/containerpart so that there are no longer separate containers that are assembledinto the base pieces. There may be variations and alternatives to theembodiments described herein and that no single embodiment should beconstrued to encompass the entire invention.

A base 140 may house one or more container therein. The containers maybe in fluidic communication with the channels and/or may be brought intofluidic communication with the channels. An end of a channel may bewithin the container or may be brought within the container. A base mayhave one or more optical indicator 142 a, 142 b that may provide avisual indication of whether sample has reached one or more containerhoused in the base. In some embodiments, the optical indicators may beoptical windows that may enable a user to see into the base. The opticalwindow may be formed from a transparent and/or translucent material.Alternatively, the optical window may be an opening without any materialtherein. The optical window may enable a user to directly view acontainer within the base. The container within the base may be formedfrom a transparent and/or translucent material that may enable a user tosee if a sample has reached the container of the base. For example, ifblood is transported along the channel to the containers, the containersmay visually indicate the presence of blood therein. In otherembodiments, the optical indicators may include other features that mayindicate the container has been filled. For example, one or more sensorsmay be provided within the base or container that may determine whethera sufficient amount of sample has been provided within the container.The one or more sensors may provide a signal to an optical indicator onthe base that may indicator whether the sample has been provided to thecontainer and/or the amount of sample that has been provided to thecontainer. For example, the optical indicator may include a display,such as but not limited to an LCD display, light display (e.g., LEDdisplay), plasma screen display that may provide an indication that thecontainers have been sufficiently filled. In alternative embodiments, anoptical indicator need not be provided, but alternative indicators maybe provided, such as but not limited to an audio indicator ortemperature controlled indicator can be used to indicate when thecontainers have been filed.

FIGS. 2A-2C provide views of a sample collection device 200 without acap 110. The sample collection device 200 may include a body 220,support 230, and base 240. The body may be connected to the support. Inthe present embodiment, the base 240 may be connected to the support atan end opposing the end connected to the body. The body may supportand/or contain at least a portion of one, two, or more channels 222 a,222 b. The channels may be capable of receiving a sample 224 a, 224 bfrom a sample receiving end 226 of the device.

The body 220 may have a hollow portion 225 therein. Alternatively, thebody may be formed from a solid piece. The channels 222 a, 222 b may beintegrally formed into the body. For example, they may be passagewaysthat pass through a solid portion of the body. The passageways may havebeen drilled through, or formed using lithographic techniques.Alternatively, the channels may be separate structures that may besupported by the body. For example, the channels may be formed of one ormore tube that may be supported by the body. In some instances, thechannels may be held in place at certain solid portions of the body andmay pass through one or more hollow portion of the body. Optionally, thebody 220 may be formed from two pieces joined together to define thechannels 222 a and 222 b therein.

The channels 222 a, 222 b may include one or more features orcharacteristics mentioned elsewhere herein. At least a portion of thechannels may be substantially parallel to one another. Alternatively,the channels may be at angles relative to one another. In someembodiments, the channels may have a first end that may be at a samplereceiving end 226 of the sample collection device. The first end of achannel may be an open end capable of receiving a sample. In someembodiments, the ends of each of the channels may be provided at thesample receiving end of the sample collection device. One, two, or morechannels may have a first end at the sample receiving end of the samplecollection device. Separate channels can be used to minimize the risk ofcross contamination of blood between one channel and another channel.Optionally, the channels may have an inverted Y configuration with thechannels starting with a common channel and the splitting into two ormore separate channels. This Y configuration may be useful in situationwhere contamination is not an issue. Optionally, an alternative methodto a Y configuration would be a straight channel and have the samplecollection vessels move to sequentially to engage the same needle from astraight channel.

In some instances, a plurality of channels may be provided. The ends ofthe channels at the sample receiving end may be in close proximity toone another. The ends of the channels at the sample receiving end may beadjacent to one another. The ends of the channels at the samplereceiving end may be contacting one another, or may be within about 0.5mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm,15 mm, or 20 mm of one another edge to edge, or center to center. Thechannels may diverge from one another from the sample receiving end. Forexample, the other ends of the channels opposing the ends of thechannels at the sample receiving ends may be further apart from oneanother. They may be greater than or equal to about 3 mm, 4 mm, 5 mm, 6mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, or 30 mm apartfrom one another edge to edge or center to center.

In some embodiments, the body 220 may have an elongated shape. The bodymay have one or more tapered portion 228 at or near the sample receivingend 226. The sides of the body may converge at the sample receiving end.The tapered portion and/or sample receiving end may be curved.Alternatively, edges may be provided. A surface of the tapered portionmay be provided at any angle relative to the longitudinal axis of thedevice. For example, the tapered portion may be about 5 degrees, 10degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 75 degreesrelative to the longitudinal axis.

The sample receiving end 226 of the device may be contacted to a sample.The sample may be provided directly from the subject. The samplereceiving end may contact the subject or a sample that is contacting orbeing exuded from the subject. For example, the sample receiving end maycontact a drop of blood on a subject's finger. The blood may enter thechannels. The blood may be transported through the channels viacapillary action, pressure differential, gravity, or any other motiveforce. The blood may travel through the channels from a sample receivingend to a sample delivery end. The sample delivery end may be in fluidcommunication or may be brought into fluid communication with one ormore containers housed within a base of the device. The sample may passfrom the channels to the containers. The sample may be driven into thecontainers via pressure differential, capillary action, gravity,friction, and/or any other motive force. Optionally, the sample mightalso be blood introduced with a pipette, syringe, etc. . . . It shouldbe understood that although FIG. 2B shows that sample B only partiallyfilling the channels 222 a, 222 b, but in most embodiments, the channelswill be fully filled with sample B when the fill process is completed.

FIGS. 3A-3B show an example of a sample collection device 300 prior tobringing the channels 322 a, 322 b into fluid communication with one ormore containers 346 a, 346 b housed within a base 340 of the device. Thesample collection device may include a cap 310, body 320, support 330,and base 340. The body and/or support may support and/or encompass atleast a portion of one, two, or more channels. The base may supportand/or encompass one, two, or more containers.

In one embodiment, a body 320 and/or support 330 may support one or morechannels 322 a, 322 b in the sample collection device. In one example,two channels are provided, although descriptions relating to atwo-channel embodiment may apply to any number of channels including butnot limited to 1, 3, 4, 5, 6, or more channels. Each of the channels mayhave a first end 323 a, 323 b that may be provided at a sample receivingend 326 of the device. The first ends of the respective channels may beopen. The channels may be open to ambient air. When the first ends ofthe channels contact a fluid, such as blood, the fluid may be drawn intothe channels. Blood may be drawn in via capillary action, or any otherof the techniques described elsewhere herein. The blood may travel alongthe length of the channels to the respective second ends 325 a, 325 b ofthe channels. The channels may be fluidically segregated from oneanother. For example, a fluid may enter a first channel 322 a via afirst end 323 a, pass through the length of the channel, and exit thefirst channel at the second end 325 a. Similarly, fluid may enter asecond channel 322 b via a first end 323 b, pass through the length ofthe channel, and exit the second channel at the second end 325 b. Thefirst and second channels may be fluidically segregated so that fluidfrom the first channel does not pass into the second channel and viceversa. In some embodiments, the fluid may pass to the second ends of thechannels without exiting initially.

The channels 322 a, 322 b may have a diverging configuration. Forexample, the first ends 323 a, 323 b of the channels may be closertogether than the second ends 325 a, 325 b of the channels. More spacemay be provided between the second ends of the channels than between thefirst ends of the channels. The first ends of the channels may or maynot be in contact with one another. The first ends of the channels maybe adjacent to one another.

A base 340 may be connected to a support 330 of the sample collectiondevice. The base 340 may or may not directly contact the support. Thebase may be movable relative to the support during use of the device. Insome embodiments, the base may slide in a longitudinal directionrelative to the support. In some instances, the base may slide in alongitudinal direction relative to the support without rotating. In someinstances, the base may slide co-axially with the support withoutrotating. In some instances, a base may rotate while moving relative tothe support. A portion of the base may fit within a portion of thesupport, or vice versa. For example, a portion of the base may beinsertable into a portion of the support and/or a portion of the supportmay be insertable into the base. One or more stop feature may beprovided in the base and/or the frame to provide a controlled degree ofmovement between the base and the support. The stop feature may includea shelf, protrusion or groove.

The base 340 may be capable of supporting one or more containers 346 a,346 b. The base may have a housing that may at least partially surroundthe one or more containers. In some instances, the containers may becompletely surrounded when the base is engaged with a support 330. Thebase may have one or more indentation, protrusion, groove, or shapedfeature to accept the containers. The base may be formed with a shapethat is complementary to the shape of the containers. The containers maybe maintained in an upright position relative to the base.

The same number of containers may be provided as the number of channels.For example, if N channels are provided, then N containers may beprovided, wherein N is a positive whole number (e.g., 1, 2, 3, 4, 5, 6,7, 8, or more). Each channel may correspond to a respective container.In one example, a sample collection device may have a first channel anda second channel, as well as a respective first container and secondcontainer. A first channel 322 a may be in or may be configured to bebrought into fluid communication with a first container 346 a, and asecond channel 322 b may be in or may be configured to be brought intofluid communication with a second container 346 b.

In some embodiments, each container may have a body 349 a, 349 b and acap 348 a, 348 b. In some instances, the container body may be formedfrom a transparent or translucent material. The container body maypermit a sample provided within the container body to be visible whenviewed from outside the container. The container body may have a tubularshape. In some instances, the container body may have a cylindricalportion. The bottom of the container may be flat, tapered, rounded, orany combination thereof. The containers may comprise an open end and aclosed end. The open end may be a top end of the container, which may beat the end of the container closer to one or more channel. The closedend may be a bottom end of the container, which may be at the end of thecontainer further from one or more channel. Various embodiments ofcontainers may be described in greater detail elsewhere herein.

A base 340 may have one or more optical indicators, such as opticalwindows 342 a, 342 b. The optical windows may be positioned over thecontainers 346 a, 346 b. In some instances, the optical windows may bepositioned over the container bodies. A single window may provide a viewto a single container or to multiple containers. In one example, thesame number of optical windows may be provided as containers. Eachoptical window may correspond to a respective container. Both theoptical window and containers may be formed of an optically transmissivematerial that may permit a user to view whether a sample has reached thecontainer from outside the sample collection device.

In some embodiments, there may be optical windows of the channels 322 aand 322 b so that a user may observe when a desired fill level has beenreached in the channels. Some embodiments where the body 320 is entirelytransparent or translucent, there may be a marker or indicator markalong the channels to note when a desired fill level has been reached.

The containers may be sized to contain a small fluid sample. In someembodiments, the containers may be configured to contain no more thanabout 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 uL, 800 uL, 700 uL, 600uL, 500 uL, 400 uL, 300 uL, 250 uL, 200 uL, 150 uL, 100 uL, 80 uL, 50uL, 30 uL, 25 uL, 20 uL, 10 uL, 7 uL, 5 uL, 3 uL, 2 uL, 1 uL, 750 mL,500 mL, 250 mL, 200 mL, 150 mL, 100 mL, 50 mL, 10 mL, 5 mL, or 1 mL. Thecontainers may be configured to contain no more than several drops ofblood, a drop of blood, or no more than a portion of a drop of blood.

The containers may contain a cap 348 a, 348 b. The plug may beconfigured to fit over an open end of the container. The cap may blockthe open end of the container. The cap may fluidically seal thecontainer. The cap may form a fluid-tight seal with the container body.For example, the cap may be gas and/or liquid impermeable.Alternatively, the cap may permit certain gases and/or liquids to passthrough. In some instances, the cap may be gas permeable while beingliquid impermeable. The cap may be impermeable to the sample. Forexample, the cap may be impermeable to whole blood, serum or plasma. Insome instances, a portion of the cap may fit into a portion of thecontainer body. The cap may form a stopper with the container body. Thecap may include a lip or shelf that may hang over a portion of thecontainer body. The lip or shelf may prevent the cap from sliding intothe container body. In some instances, a portion of a cap may overlie atop and/or side of the container body. Any description herein ofcontainers may be applied in combination with the sample collectiondevice. Optionally, some embodiments may include an additional part inthe vessel assembly such as cap holder. In one embodiment, the purposeof the cap holder is to maintain a tight seal between the cap andcontainer. In one embodiment, the cap holder engages an attachment, lip,indentation, or other attachment location on the outside of thecontainer to hold the cap in position. Optionally, some embodiments cancombine the function of both the cap and the cap holder into onecomponent.

One or more engagement assemblies may be provided. The engagementassembly may include a channel holder 350 and/or a force-exertingcomponent, such as a spring 352 or elastic. In one embodiment, theholder 350 may keep the adapter channel 354 affixed to the support. Aswill be described elsewhere herein, the adaptor channel 354 may beformed integrally with the collection channel or may be a discreteelement that may be a stand-alone piece, part of the collection channel,or part of the container. In one embodiment, the holder 350 may preventthe adapter channel 354 from sliding relative to the support. The holder350 may optionally provide a support upon which a force-exertingcomponent, such as a spring, may rest.

In one example, the engagement assemblies may each include a spring 352which may exert a force so that the base 340 is at an extended state,when the spring is at its natural state. When the base is at itsextended state, space may be provided between the containers 346 a, 346b and the engagement assemblies. In some instances, when the base 340 isin its extended state, the second ends of the channels may or may notcontact the caps of the containers. The second ends of the channels 325a, 325 b may be in a position where they are not in fluid communicationwith the interiors of the containers.

A sample collection device may have any number of engagement assemblies.For example, the same number of engagement assemblies may be provided asnumber of channels. Each channel may have an engagement assembly. Forexample, if a first channel and a second channel are provided, a firstengagement assembly may be provided for the first channel, and a secondengagement assembly may be provided for the second channel. The samenumber of engagement assemblies and containers may be provided.

In one embodiment, the engagement assembly may house an adapter channel354 such as but not limited to an elongate member with angled, taperedor pointed end 327 a and 327 b. It should be understood that in someembodiments, the ends 327 a and 327 b are part of a needle that isformed separate from the channels 322 a and 322 b and then coupled tothe channels 322 a and 322 b. The needles may be formed of the same ordifferent material from the body defining the channels 322 a and 322 b.For example, some may use a metal to form the needles and a polymer orplastic material for the body defining channels 322 a and 322 b.Optionally, some embodiments may form the ends 327 a and 327 b on amember that is integrally formed with the channels 322 a and 322 b. Insome instances, the second end of the channel may be configured topenetrate a material, such as a cap 348 a, 348 b of the container. Insome embodiments, a portion of the adaptor channel 354 may be insertablewithin the collection channel or a portion of the collection channel maybe insertable within the adaptor channel, or the two may be configuredto align flush. Optionally, some embodiments may integrally form theadapter channel 354 with the collection channel 322 a. It should beunderstood that FIG. 3B (and 4B) shows that sample B only partiallyfilling the channels 122 a, 122 b, but, in most embodiments, thechannels will be fully filled with sample B when the fill process iscompleted. There may be variations and alternatives to the embodimentsdescribed herein and that no single embodiment should be construed toencompass the entire invention.

FIGS. 4A-4B show an example of a sample collection device 400 havingchannels 422 a, 422 b that are in fluid communication with the interiorof containers 446 a, 446 b within the device. The sample collectiondevice may include a cap 410, body 420, support 430, and base 440. Thebody and/or support may support and/or encompass at least a portion ofone, two, or more channels. The base may support and/or encompass one,two, or more containers.

In one embodiment, a body 420 and/or support 430 may support one or morechannels 422 a, 422 b in a sample collection device. For example, afirst channel and second channel may be provided. Each of the channelsmay have a first end 423 a, 423 b that may be provided at a samplereceiving end 426 of the device. The first ends of the respectivechannels may be open. The channels may be open to ambient air. When thefirst ends of the channels contact a fluid, such as blood, the fluid maybe drawn into the channels. The fluid may be drawn in via capillaryaction, or any other of the techniques described elsewhere herein. Thefluid may travel along the length of the channels to the respectivesecond ends 425 a, 425 b of the channels. In some embodiments, the fluidmay reach the second ends of the channels via capillary action or othertechniques described herein. In other embodiments, the fluid need notreach the second ends of the channels. The channels may be fluidicallysegregated from one another.

In some embodiments, the fluid may pass to the second ends of thechannels without exiting when the channels are not in fluidcommunication with the interiors of the containers 446 a, 446 b. Forexample, the fluid may be drawn into the channel via capillary action,which may cause the fluid to flow to or near the end of the channelwithout causing the fluid to exit the channel.

A base 440 may be connected to a support 430 of the sample collectiondevice. The base may be movable relative to the support during use ofthe device. In some embodiments, the base may slide in a longitudinaldirection relative to the support. In one example, the base may have (i)an extended position where the channels are not in fluid communicationwith the interior of the containers, and (ii) a compressed positionwhere the channels are in fluid communication with the interior of thecontainers. A sample collection device may be initially provided in anextended state, as shown in FIG. 3. After the sample has been collectedand flown through the length of the channel, a user may push the base into provide the sample collection device in its compressed state, asshown in FIG. 4. Once the base has been pushed in, the base maynaturally remain pushed in, or may spring back out to an extended state,once the pushing force is removed. In some instances, a base may bepulled out to an extended state, or may be pulled out completely toprovide access to containers therein.

The base 440 may be capable of supporting one or more containers 446 a,446 b. The base may have a housing that may at least partially surroundthe one or more containers. In some instances, the containers may becompletely surrounded when the base is engaged with a support 430. Thebase may have one or more indentation, protrusion, groove, or shapedfeature to accept the containers. The base may be formed with a shapethat is complementary to the shape of the containers. The containers maybe maintained in an upright position relative to the base.

The same number of containers may be provided as the number of channels.Each channel may correspond to a respective container. In one example, asample collection device may have a first channel and a second channel,as well as a respective first container and second container. A firstchannel 422 a may be in or may be configured to be brought into fluidcommunication with a first container 446 a, and a second channel 422 bmay be in or may be configured to be brought into fluid communicationwith a second container 446 b. The first channel may initially not be influid communication with a first container and the second channel mayinitially not be in fluid communication with the second container. Thefirst and second channels may be brought into fluid communication withthe interiors of the first and second containers respectively when thebase is pushed in relative to the support. The first and second channelsmay be brought into fluid communication with the first and secondcontainers simultaneously. Alternatively, they need not be brought intofluid communication simultaneously. The timing of the fluidcommunication may depend on the height of the container and/or thelength of the channel. The timing of the fluid communication may dependon the relative distances between the second end of the channel and thecontainer.

In some embodiments, each container may have a body 449 a, 449 b and acap 448 a, 448 b. The container body may have a tubular shape. In someinstances, the container body may have a cylindrical portion. The bottomof the container may be flat, tapered, rounded, or any combinationthereof. The containers may comprise an open end and a closed end. Theopen end may be a top end of the container, which may be at the end ofthe container closer to one or more channel. The closed end may be abottom end of the container, which may be at the end of the containerfurther from one or more channel.

A base 440 may have one or more optical indicators, such as opticalwindows 442 a, 442 b. The optical windows may be positioned over thecontainers 446 a, 446 b. In some instances, the optical windows may bepositioned over the container bodies. Both the optical window andcontainers may be formed of an optically transmissive material that maypermit a user to view whether a sample has reached the container fromoutside the sample collection device. In some embodiments, thecontainers may incorporate markings on the containers themselves toindicate fill level requirements.

The containers may contain a cap 448 a, 448 b. The cap may be configuredto fit over an open end of the container. The cap may block the open endof the container. The cap may fluidically seal the container. The capmay form a fluid-tight seal with the container body. For example, thecap may be impermeable to whole blood, serum or plasma. In someinstances, a portion of the cap may fit into a portion of the containerbody. The cap may include a lip or shelf that may hang over a portion ofthe container body. In some embodiments, the cap may have a hollow ordepression. The hollow or depression may assist with guiding a secondend of the channel to a center of the cap. In some instances, when thesample collection device is in an extended state, a second end of achannel 425 a, 425 b may lie above the cap of the container. The secondend of the channel may or may not contact the container cap. In someinstances, the second end of the channel may rest within a hollow ordepression of the cap. In some instances, the second end of the channelmay partially penetrate the cap without reaching the interior of thecontainer. Optionally, some embodiments of the cap might include acrimping piece to hold vacuum.

A second end of a channel may have an angled, tapered or pointed end 427a and 427 b. It should be understood that in some embodiments, the ends427 a and 427 b are part of a needle that is formed separate from thechannels 422 a and 422 b and then coupled to the channels 422 a and 422b. The needles may be formed of the same or different material from thebody defining the channels 422 a and 422 b. For example, some may use ametal to form the needles and a polymer or plastic material for the bodydefining channels 422 a and 422 b. Optionally, some embodiments may formthe ends 427 a and 427 b on a member that is integrally formed with thechannels 422 a and 422 b. In some instances, the second end of thechannel may be configured to penetrate a material, such as a cap 448 a,448 b of the container. The cap may be formed of a material that mayprevent sample from passing through in the absence of a penetratingmember. The cap may be formed from a single solid piece. Alternatively,the cap may include a slit, opening, hole, thin portion, or any otherfeature that may accept a penetrating member. A slit or other openingmay be capable of retaining sample therein, when the penetrating memberis not in the slit or opening, or when the penetrating member is removedfrom the slit or opening. In some instances, the cap may be formed froma self-healing material, so that when a penetrating member is removed,the opening formed by the penetrating member closes up. The second endof the channel may be a penetrating member that may pass through the capand into the interior of the container. In some embodiment, it should beclear that the penetrating member may be hollow needles that allowsample to pass through, and not just needles for piercing. In someembodiments, the piercing tip can be a non-coring design such as but notlimited to a tapered cannula that pierces without coring the capmaterial.

One or more engagement assemblies may be provided. The engagementassembly may include a channel holder 450 and/or a force-exertingcomponent, such as a spring 452 or elastic. In one embodiment, theholder 450 may keep the adaptor channel 454 affixed to the support. Aswill be described elsewhere herein, the adaptor channel 454 may beformed integrally with the collection channel or may be a discreteelement that may be a stand-alone piece, part of the collection channel,or part of the container. In one embodiment, the holder 450 may preventthe adaptor channel 454 from sliding relative to the support. The holder450 may optionally provide a support upon which a force-exertingcomponent, such as a spring, may rest.

In one example, the engagement assemblies may include a spring 452 whichmay exert a force so that the base is at its extended state, when thespring is at its natural state. When the base is at its extended state,space may be provided between the containers 446 a, 446 b and theengagement assemblies. The second ends of the channels 425 a, 425 b maybe in a position where they are not in fluid communication with theinteriors of the containers.

A sample collection device may have any number of engagement assemblies.For example, the same number of engagement assemblies may be provided asnumber of channels. Each channel may have an engagement assembly. Forexample, if a first channel and a second channel are provided, a firstengagement assembly may be provided for the first channel, and a secondengagement assembly may be provided for the second channel. In oneembodiment, the same number of engagement assemblies and containers maybe provided.

When the base is pressed in, the spring 452 may be compressed. Thesecond ends 425 a, 425 b of the channels may penetrate the caps of thecontainers. The second ends of the channels may enter the interior ofthe container. In some instances, a force may be provided to drive thefluid from the channels into the containers. For example, a pressuredifferential may be generated between the first and second ends of thechannels. A positive pressure may be provided at the first end 423 a,423 b of the channels and/or a negative pressure may be provided at thesecond end of the channels. The positive pressure may be positiverelative to the pressure at the second end of the channel, and/orambient air. The negative pressure may be negative relative to thepressure at the first end of the channel and/or ambient air. In oneexample, the containers may have a vacuum therein. When the second endof a channel penetrates a container, the negative pressure within thecontainer may pull the sample into the container. In alternativeembodiments, the sample may enter the container driven by capillaryforces, gravity, or any other motive force. There may be variations andalternatives to the embodiments described herein and that no singleembodiment should be construed to encompass the entire invention.

In some instances, different types of motive forces may be used atdifferent stages of sample collection. Thus, one type of motive forcemay be used to draw the sample into the channel, and then a differenttype of motive force may be used to move sample from the channel intothe container. For example, a capillary force may draw the sample into achannel, and a pressure differential may drive the sample from thechannel into the container. Any combinations of motive forces may beused to draw sample into the channel and into the container. In someembodiments, the motive force(s) used to draw sample into the channel isdifferent from motive force(s) used to draw sample into the container.In some alternative embodiments, the motive force(s) may be the same foreach stage. In some embodiments, the motive force(s) are appliedsequentially or at defined time periods. By way of non-limiting example,motive force(s) to draw sample into the container is not applied untilthe at least one channel has reach a minimum fill level. Optionally,motive force(s) to draw sample into the container is not applied untilthe at least two channels have each reach a minimum fill level for thatchannel. Optionally, motive force(s) to draw sample into the containeris not applied until all channels have each reach a minimum fill levelfor that channel. In some embodiments, the motive force(s) are appliedsimultaneously.

Some embodiments may use a pressurized gas source coupled to the samplecollection device and configured to push collected bodily fluid from theone or more channels into their respective containers. Optionally, somemay use a vacuum source not associated with the containers to pullsample fluid towards the containers.

Additional, some embodiments of the channel may be configured such thatthere is sufficient capillary force within the channel such that oncefilled, the force is greater than that of gravity so that sample doesnot escape from the channel based only on gravitation force. Anadditional motive force is used to break the hold of the capillaryaction of the channel(s). Optionally, as described elsewhere herein, adevice such as but not limited to a sleeve may contain the bodily fluidfrom exiting the channel at the end closest to the container, thusminimizing any loss until transfer to the container is initiated.

Optionally, other materials such as but not limited to a lyosphere,sponge, or other motive force provider may be used to provide motiveforce that draws sample into the container. When multiple forces arebeing used, this may be a primary, secondary, or tertiary motive forceto draw sample into the container. Optionally, some embodiments mayinclude a push-type motive force provider such as but not limited to aplunger to move the sample in a desired manner.

Some time may elapse after a sample has been introduced to a channel fortraveling along the length of the channel. A user may introduce a sampleto the sample collection device and may wait for the sample to travelthe length of the channel. One or more optical indicator may beprovided, which may indicate whether the sample has reached a desiredfill level, such as not limited to the end of the channel. In otherembodiments, the user may wait a predetermined amount of time beforepushing in the base. The base may be pushed in after the user hasdetermined the sample has traveled a sufficient length of the channeland/or a sufficient amount of time has passed since the sample wasintroduced. After the base is pushed in, the channels may be broughtinto fluid communication with the containers, and sample may flow fromthe channel into the containers. An optical indicator may be provided sothat a user may know when the containers have been filled.

Once the containers have been filled, they may be transferred to adesired location, using systems and methods described elsewhere herein.In some instances, the entire sample collection device may betransferred. The cap may be placed on the sample collection device fortransfer. In other embodiments, the base portion and/or support portionmay be removable from the rest of the device. In one example, the basemay be removed from the sample collection device, and the containers maybe transferred along with the base. Alternatively, the base may beremoved from the sample collection device to provide access to thecontainers, and the containers may be removed from the device andtransmitted. The removal of the base may involve some disassembly of thesample collection device to detach the base. This may involve usingsufficient force to overcome detents or stops built into the device toprevent accidental disengagement. Optionally, some other positive actsuch as but not limited to disengaging a latch or other lockingmechanism may be performed by a user before detaching the base.Optionally, some embodiments may allow for removal of the containerswithout removal of the base, but allow for access to the containers byway of openings, access ports, or open-able covers on the base.

In some embodiments, one or more of the channels and/or containers maycomprise features described elsewhere herein, such as separationmembers, coatings, anti-coagulants, beads, or any other features. In oneexample, the sample introduced to the sample collection device may bewhole blood. Two channels and respective containers may be provided. Inthis non-limiting example, each of the channels has a coating such asbut not limited to an anti-coagulant coating in the channel. Such ananti-coagulant coating can serve one or more of the following functions.First, the anti-coagulant can prevent whole blood from clotting insidethe channel during the sample collection process. Depending on theamount of whole blood to be collected, clotting could prematurely clogthe channel before sufficient amount of blood has been brought into thechannel. Another function is to introduce anti-coagulant into the wholeblood sample. By have the anti-coagulant in the channel, this processcan begin earlier in the collection process versus some embodimentswhich may only have it the containers 446 a or 446 b. This earlyintroduction of anti-coagulant may also be advantageous in case thewhole blood sample will be led along a pathway that may have portionsthat are not coated with anti-coagulant, such as but not limited to, theinner surfaces of a needle connected to the channels 422 a or 422 b.Optionally, some embodiments may include surfactants that can be used tomodify the contact angle (wettability) of a surface.

In some embodiments the inner surface of the channel and/or othersurfaces along the fluid pathway such as but not limited to the sampleinlet to the interior of a sample collection vessel may be coated with asurfactant and/or an anti-coagulant solution. The surfactant provides awettable surface to the hydrophobic layers of the fluidic device andfacilitate filling of the metering channel with the liquid sample, e.g.,blood. The anti-coagulant solution helps prevent the sample, e.g.,blood, from clotting when provided to the fluidic device. Exemplarysurfactants that can be used include without limitation, Tween,TWEEN®20, Thesit®, sodium deoxycholate, Triton, Triton®X-100, Pluronicand/or other non-hemolytic detergents that provide the proper wettingcharacteristics of a surfactant. EDTA and heparin are non-limitinganti-coagulants that can be used. In one non-limiting example, theembodiment the solution comprises 2% Tween, 25 mg/mL EDTA in 50%Methanol/50% H20, which is then air dried. A methanol/water mixtureprovides a means of dissolving the EDTA and Tween, and also driesquickly from the surface of the plastic. The solution can be applied tothe channel or other surfaces along the fluid flow pathway by anytechnique that will ensure an even film over the surfaces to be coated,such as, e.g., pipetting, spraying, printing, or wicking.

It should also be understood for any of the embodiments herein that acoating in the channel may extend along the entire path of the channel.Optionally, the coating may cover a majority but not all of the channel.Optionally, some embodiments may not cover the channel in the areasnearest the entry opening to minimize the risk of cross-contamination,wherein coating material from one channel migrates into nearby channelsby way of the channels all being in contact with the target sample fluidat the same time and thus having a connecting fluid pathway.

Although embodiments herein are shown with two separate channels in thesample collection device, it should be understood that some embodimentsmay use more than two separate channels. Optionally, some embodimentsmay use less than two fully separate channels. Some embodiments may onlyuse one separate channel. Optionally, some embodiments may use aninverted Y-channel that starts initially as one channel and then splitsinto two or more channels. Any of these concepts may be adapted for usewith other embodiments described herein.

Collection Device with Self-Supporting Collection Channels

FIGS. 5A-5B provide another example of a sample collection device 500provided in accordance with an embodiment described herein. The samplecollection device may include a collection device body 520, support 530,and base 540. In some instances, a cap may be optionally provided. Thecollection device body may contain one or more collection channels 522a, 522 b defined by collection tubes, which may be capable of receivingsample. A base may have one or more optical indicator 542 a, 542 b thatmay provide a visual indication of whether sample has reached one ormore container housed in the base. A support may have one or moreoptical indicator 532 a, 532 b that may provide a visual indication ofwhether sample has reached or passed through a portion of the channels.

A collection device body 520 of a sample collection device may containat least a portion of one or more tubes with channels 522 a, 522 btherein. Optionally, the device collection body 520 may also definechannels that couple to channels 522 a, 522 b defined by the tubes. Insome embodiments, a portion of the channels may extend beyond thecollection device body. The channels may extend beyond one end or twoends of the collection device body.

The collection device body 520 may be connected to a support 530. Thesupport may contain a portion of one or more channels therein. Thecollection device body may be permanently affixed to the support or maybe removable with respect to the support. In some instances, thecollection device body and the support may be formed of a singleintegral piece. Alternatively, the collection device body and supportmay be formed from separate pieces.

During the operation of the device the collection device body 520 andsupport 530 may move relative to one another. In some instances, aportion of the body 520 may be insertable within the support 530 and/ora portion of the support may be insertable within the body. The body maybe capable of moving relative to the support. In some instances, asample collection device may have a longitudinal axis extending alongthe length of the sample collection device. The body and/or support maymove relative to one another in the direction of the longitudinal axis.The body and/or support may be capable of moving a limited distancerelative to one another. The body and/or support may move co-axiallywithout rotational motion. Alternatively, rotational motion may beprovided.

The collection device body 520 may be formed from an opticallytransmissive material. For example, the collection device body may beformed from a transparent or translucent material. Alternatively, thebody may be formed from an opaque material. The support 530 may beformed from an optically opaque, translucent, or transparent material.The support may or may not have the same optical characteristics of thecollection device body. The support may be formed from a differentmaterial as the collection device body, or from the same material as thecollection device body. There may be variations and alternatives to theembodiments described herein and that no single embodiment should beconstrued to encompass the entire invention.

The collection device body, support, and/or base may have any shape orsize. In some examples, the collection device body, support, and/or basemay have a circular, elliptical, triangular, quadrilateral (e.g.,square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, orany other cross-sectional shape. The cross-sectional shape may remainthe same or may vary along the length. The cross-sectional shape may bethe same for the body, support, and base, or may vary. In someinstances, the collection device body, support, and/or base may have across-sectional area of less than or equal to about 10 cm2, 7 cm2, 5cm2, 4 cm2, 3 cm2, 2.5 cm2, 2 cm2, 1.5 cm2, 1 cm2, 0.8 cm2, 0.5 cm2, 0.3cm2, or 0.1 cm2. The cross-sectional area may vary or may remain thesame along the length. The cross-sectional size may be the same for thecollection body, support, and/or base, or may vary. The collectiondevice body, support, and/or base may have a length of less than orequal to about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm,4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm. The collection device bodymay have a greater or lesser length than support or base, or an equallength to the support, or base.

The channels 522 a, 522 b may be supported by the device body 520 and/orthe support 530. In some instances, the entire length of the tubes orthe channels therein may be encompassed within the combination of thedevice body and the support. Alternatively, the channels may extendbeyond the device body and/or support as seen in FIG. 5. In someinstances, the channels may extend beyond one end of the devicebody/support combination, or beyond both ends. In some instances, aportion of the channels may be within the device body and a portion ofthe channels may be within the support. The position of the channels maybe affixed by the device body and/or the support. In some instances, thechannels may be affixed to device body and/or not move relative to thedevice body. The channels may be movable relative to the support. Insome instances, a plurality of channels may be provided. At least aportion of the channels may be substantially parallel to one another.The channels may be parallel to one another and/or a longitudinal axisextending along a length of the sample collection device. Alternatively,no portion of the channels need be parallel to one another. In someinstances, at least a portion of the channels are not parallel to oneanother. The channels may be slightly bent. Optionally, they may bestraight, but aligned to be closer to one another as they near thesample collection point. It should be understood that the tubes definingthe channels 522 a and 522 b may be made of optically transparent,transmissive, or other material sufficient to provide a detectablechange that sample has reached a desired fill level in at least onechannel. Optionally, the detectable change can be used to detect whenboth channels reach at least the desired fill level.

A base 540 may be provided within the sample collection device. The basemay be connected to the support 530. In some instances, a portion of thebase 540 may insertable within the support 530 and/or a portion of thesupport may be insertable within the base. The base may be fixedrelative to the support or may be movable relative to the support. Thebase may be provided at an end of the support opposite an end of thesupport connected to the body. The base may be formed as a separatepiece from the support. The base may be separable from the support.Alternatively, the base may be affixed to the support and/or formed asan integral piece with the support.

A base 540 may house one or more container therein. The containers maybe in fluidic communication with the channels and/or may be brought intofluidic communication with the channels. An end of a channel may bewithin the container or may be brought within the container. A base mayhave one or more optical indicator 542 a, 542 b that may provide avisual indication of whether sample has reached one or more containerhoused in the base. In some embodiments, the optical indicators may beoptical windows that may enable a user to see into the base. The opticalwindow may be formed from a transparent and/or translucent material.Alternatively, the optical window may be an opening without any materialtherein. The optical window may enable a user to directly view acontainer within the base. The container within the base may be formedfrom a transparent and/or translucent material that may enable a user tosee if a sample has reached the container of the base. For example, ifblood is transported along the channel to the containers, the containersmay show the blood therein. In other embodiments, the optical indicatorsmay include other features that may indicate the container has beenfilled. For example, one or more sensor may be provided within the baseor container that may determine whether a sufficient amount of samplehas been provided within the container. The sensor may provide a signalto an optical indicator on the base that may indicator whether thesample has been provided to the container and/or the amount of samplethat has been provided to the container. For example, the opticalindicator may include a display, such as an LCD display, light display(e.g., LED display), plasma screen display that may provide anindication that the containers have been sufficiently filled. Inalternative embodiments, an optical indicator need not be provided, butalternative indicators may be provided, such as but not limited to, anaudio indicator, temperature controlled indicator, or other device thatmay indicate by a detectable signal, such as one detectable by a user,when the containers have been filed.

A support 530 may have one or more optical indicator 532 a, 532 b thatmay provide a visual indication of whether sample has reached or passthrough a portion of a channel housed by the support. In someembodiments, the optical indicators may be optical windows that mayenable a user to see into the support. The optical window may be formedfrom a transparent and/or translucent material. Alternatively, theoptical window may be an opening without any material therein. Theoptical window may enable a user to directly view a portion of a channelwithin the support. The channels may be formed from a transparent and/ortranslucent material that may enable a user to see if a sample hasreached the portion of the channel underlying the optical window. Inother embodiments, the optical indicators may include other featuresthat may indicate the sample has passed through a portion of thechannel, such as sensors described elsewhere herein.

Referring now to FIGS. 6A-6B, additional views of a sample collectiondevice 500 are provided in accordance with one embodiment describedherein.

In some embodiments, a portion of the tubes containing channels 522 a,522 b may extend beyond the collection device body 520. The portion ofthe channels that extend beyond may include portions of the channelsthat are configured to receive a sample from the subject. In oneexample, the channels may have a first end 523 a, 523 b that may be asample receiving end of the channels.

The channels may optionally be defined by a rigid material.Alternatively, the channels may be defined by a flexible material or mayhave flexible components. The channels may or may not be designed tobend or curve. The channels may or may not be substantially parallel toone another. In some instances, the first ends of the channels may besome distance apart when in a relaxed state. The first ends of thechannels may remain that distance apart during operation of the device.Alternatively, the first ends of the channels may be brought closertogether. For example, the first ends of the channels may be squeezedtogether. Each open end of the channels may separately receive a sample.The sample may be received sequentially. The sample may be from the samesubject. Alternatively, the channels may be capable of receiving thesame sample simultaneously.

The channels 522 a, 522 b may include one or more features orcharacteristics mentioned elsewhere herein. At least a portion of thechannels may be substantially parallel to one another. Alternatively,the channels may be at angles relative to one another. In someembodiments, the channels may have a first end that may be at a samplereceiving end 526 of the sample collection device. The first end of achannel may be an open end capable of receiving a sample. In someembodiments, the ends of each of the channels may be provided at thesample receiving end of the sample collection device. One, two, or morechannels may have a first end at the sample receiving end of the samplecollection device.

In some embodiments, the device body 520 may be movable relative to thesupport 530. A portion of the device body may be insertable within thesupport or vice versa. In one example, the device body may have a lip527 and an interior portion 529. The lip may have a greatercross-sectional area than the interior portion. The interior portion maybe capable of being inserted into the support. The lip may act as a stopto prevent the entire body from being inserted into the support. The lipmay rest on a shoulder of the support.

FIGS. 7A-7B shows partial cutaway views of an example of a samplecollection device 700 provided in accordance with an embodimentdescribed herein. The sample collection device in an extended state,prior to bringing the channels 722 a, 722 b into fluid communicationwith one or more containers 746 a, 746 b housed within a base 740 of thedevice. The sample collection device may include a body 720, support730, and base 740. The body and/or support may support and/or encompassat least a portion of one, two or more channels. The base may supportand/or encompass one, two or more containers. There may be variationsand alternatives to the embodiments described herein and that no singleembodiment should be construed to encompass the entire invention.

In one embodiment, a body 720 and/or support 730 may support one or morechannels 722 a, 722 b in a sample collection device. In one example, twochannels are provided, though descriptions relating to a two-channelembodiment may apply to any number of channels including but not limitedto 1, 3, 4, 5, 6 or more channels. Each of the channels may have a firstend 723 a, 723 b that may be a sample receiving end of the device. Thefirst ends of the respective channels may be open. The channels may beopen to ambient air. When the first ends of the channels contact afluid, such as blood, the fluid may be drawn into the channels. Fluidmay be drawn in via capillary action, or any other of the techniquesdescribed elsewhere herein. The fluid may travel along the length of thechannels to the respective second ends of the channels. The channels maybe fluidically segregated from one another. For example, a fluid mayenter a first channel 722 a via a first end 723 a, pass through thelength of the channel, and exit the first channel at the second end.Similarly, fluid may enter a second channel 722 b via a first end 723 b,pass through the length of the channel, and exit the second channel atthe second end. The first and second channels may be fluidicallysegregated so that fluid from the first channel does not pass into thesecond channel and vice versa. In some embodiments, the fluid may passto the second ends of the channels without exiting initially.

The channels 722 a, 722 b may have a parallel configuration. Forexample, the first ends 723 a, 723 b of the channels may be about thesame distance apart as the second ends of the channels. The first endsof the channels may or may not be in contact with one another.

A support 730 may have one or more optical indicators, such as opticalwindows 732 a, 732 b. The optical windows may be positioned over thechannels 722 a, 722 b. In some instances, the optical windows may bepositioned over portions of the channels. A single window may provide aview to a single channel portion or to multiple channel portions. In oneexample, the same number of optical windows may be provided as channels.Each optical window may correspond to a respective channel. Both theoptical window and channels may be formed of an optically transmissivematerial that may permit a user to view whether a sample has reachedand/or passed through the underlying portion of the channel from outsidethe sample collection device. Such determination may be useful indetermining when to compress the sample collection device.

A base 740 may be connected to a support 730 of the sample collectiondevice. The base may or may not directly contact the support. The basemay be fixed relative to the support during use of the device. In someinstances, the base may be removable from the support. A portion of thebase may be insertable into the support and/or vice versa. In someembodiments, the base may slide out from the support in a longitudinaldirection relative to the support. In some instances, the base may slideco-axially with the support without rotating. In some instances, a basemay rotate while moving relative to the support.

The base 740 may be capable of supporting one or more containers 746 a,746 b. The base may have a housing that may at least partially surroundthe one or more containers. In some instances, the containers may becompletely surrounded when the base is engaged with a support 730. Theheight of the base may extend beyond the height of the containers.Alternatively, the height of the base may extend to the same degree orless than the height of the containers. The base may have one or moreindentation, protrusion, groove, or shaped feature to accept thecontainers. The base may be formed with a shape that is complementary tothe shape of the containers. For example, the base may have one or moretube shaped indentation into which tube shaped containers may snuglyfit. The containers may friction-fit into the base. The containers maybe maintained in an upright position relative to the base. There may bevariations and alternatives to the embodiments described herein and thatno single embodiment should be construed to encompass the entireinvention.

The same number of containers may be provided as the number of channels.For example, if N channels are provided, then N containers may beprovided, wherein N is a positive whole number (e.g., 1, 2, 3, 4, 5, 6,7, 8, or more). Each channel may correspond to a respective container.In one example, a sample collection device may have a first channel anda second channel, as well as a respective first container and secondcontainer. A first channel 722 a may be in or may be configured to bebrought into fluid communication with a first container 746 a, and asecond channel 722 b may be in or may be configured to be brought intofluid communication with a second container 746 b.

In some embodiments, each container may have a body 749 a, 749 b and acap 748 a, 748 b. The containers may have any features orcharacteristics as described elsewhere herein.

A base 740 may have one or more optical indicators, such as opticalwindows 742 a, 742 b. The optical windows may be positioned over thecontainers 746 a, 746 b. In some instances, the optical windows may bepositioned over the container bodies. A single window may provide a viewto a single container or to multiple containers. In one example, thesame number of optical windows may be provided as containers. Eachoptical window may correspond to a respective container. Both theoptical window and containers may be formed of an optically transmissivematerial that may permit a user to view whether a sample has reached thecontainer from outside the sample collection device. Such visualassessment may be useful in determining when the sample has reached thecontainers, and when the base can be removed from the sample collectiondevice.

One or more engagement assemblies may be provided. The engagementassembly may include a channel holder 750 and/or a force-exertingcomponent, such as a spring 752 or elastic. In one embodiment, theholder 750 may keep the adaptor channel 754 affixed to the support. Aswill be described elsewhere herein, the adaptor channel 754 may beformed integrally with the collection channel or may be a discreteelement that may be a stand-alone piece, part of the collection channel,or part of the container. In one embodiment, the holder 750 may preventthe adaptor channel 754 from sliding relative to the support. The holder750 may optionally provide a support upon which a force-exertingcomponent, such as a spring, may rest.

In one example, the engagement assemblies may include a spring 752 whichmay exert a force so that the body 720 is at an extended state, when thespring is at its natural state. When the body is at its extended state,space may be provided between the containers 746 a, 746 b and theengagement assemblies. When a body is in its extended state, theinterior portion 729 of the body may be exposed and/or uncovered by thesupport 730. In some instances, when the body is in its extended state,the second ends of the channels 722 a, 722 b may or may not contact thecaps of the containers. The second ends of the channels may be in aposition where they are not in fluid communication with the interiors ofthe containers. There may be variations and alternatives to theembodiments described herein and that no single embodiment should beconstrued to encompass the entire invention.

A sample collection device may have any number of engagement assemblies.For example, the same number of engagement assemblies may be provided asnumber of channels. Each channel may have an engagement assembly. Forexample, if a first channel and a second channel are provided, a firstengagement assembly may be provided for the first channel, and a secondengagement assembly may be provided for the second channel. The samenumber of engagement assemblies and containers may be provided.

FIGS. 8A-8B provide an example of a sample collection device 800 havingchannels 822 a, 822 b that are in fluid communication with the interiorof containers 846 a, 846 b within the device. The sample collectiondevice may include a body 820, support 830, and base 840. The bodyand/or support may support and/or encompass at least a portion of one,two or more channels. The channels may extend beyond an end of the body.The base may support and/or encompass one, two or more containers.

In one embodiment, a body 820 and/or support 830 may support one or morechannels 822 a, 822 b in a sample collection device. For example, afirst channel and second channel may be provided. Each of the channelsmay have a first end 823 a, 823 b that may be provided at a samplereceiving end of the device that may extend beyond the body. The firstends of the respective channels may be open. The channels may be open toambient air. The channels may be rigid or may be flexible. In someembodiments, the channels may have a length that may permit them to bebent into contact with one another. When the first ends of the channelscontact a fluid, such as blood, the fluid may be drawn into thechannels. Each channel end may be separately contacted to a fluid, whichis drawn into the respective channel. This may involve angling thesample collection device so that only one opening into the channel is incontact with the sample fluid at any one time. Alternatively, allchannels may be simultaneously contacted to the same sample which issimultaneously drawn into the respective channels. Alternatively,multiple but not all channels may be simultaneously contacted to thesame sample which is then simultaneously drawn into the respectivechannels. The fluid may be drawn in via capillary action, or any otherof the techniques described elsewhere herein. The fluid may travel alongthe length of the channels to the respective second ends of thechannels. In some embodiments, the fluid may reach the second ends ofthe channels via capillary action or other techniques described herein.In other embodiments, the fluid need not reach the second ends of thechannels. The channels may be fluidically segregated from one another.

In some embodiments, the fluid may pass to the second ends of thechannels without exiting when the channels are not in fluidcommunication with the interiors of the containers 846 a, 846 b. Forexample, the fluid may be drawn into the channel via capillary action,which may cause the fluid to flow to or near the end of the channelwithout causing the fluid to exit the channel.

The body 820 may be movable relative to the support 830 during use ofthe device. In some embodiments, the body may slide in a longitudinaldirection relative to the support. In one example, the body may have (i)an extended position where the channels are not in fluid communicationwith the interior of the containers, and (ii) a compressed positionwhere the channels are in fluid communication with the interior of thecontainers. A sample collection device may be initially provided in anextended state, as shown in FIG. 7. After the sample has been collectedand flown through the length of the channel, a user may push the body into provide the sample collection device in its compressed state, asshown in FIG. 8. In some instances, when the body is in an extendedstate, an interior portion of the body is exposed. When the body is in acompressed state, the interior portion of the body may be covered by thesupport. A lip of the body may contact the support. Once the body hasbeen pushed in, the body may naturally remain pushed in, or may springback out to an extended state, once the pushing force is removed. Insome instances, a body may be pulled out to an extended state, or may bepulled out completely to provide access to containers therein.Optionally, in some assemblies, removal of the body will not provideaccess to the containers.

A base 840 may be connected to a support 830 of the sample collectiondevice. The base 840 may be capable of supporting one or more containers846 a, 846 b. The base may have a housing that may at least partiallysurround the one or more containers. In some instances, the containersmay be completely surrounded when the base is engaged with a support830. The base may have one or more indentation, protrusion, groove, orshaped feature to accept the containers. The base may be formed with ashape that is complementary to the shape of the containers. Thecontainers may be maintained in an upright position relative to thebase.

The same number of containers may be provided as the number of channels.Each channel may correspond to a respective container. In one example, asample collection device may have a first channel and a second channel,as well as a respective first container and second container. A firstchannel 822 a may be in or may be configured to be brought into fluidcommunication with a first container 846 a, and a second channel 822 bmay be in or may be configured to be brought into fluid communicationwith a second container 846 b. The first channel may initially not be influid communication with a first container and the second channel mayinitially not be in fluid communication with the second container. Thefirst and second channels may be brought into fluid communication withthe interiors of the first and second containers respectively when thebody is pushed in relative to the support. The first and second channelsmay be brought into fluid communication with the first and secondcontainers simultaneously. Alternatively, they need not be brought intofluid communication simultaneously. The timing of the fluidcommunication may depend on the height of the container and/or thelength of the channel. The timing of the fluid communication may dependon the relative distances between the second end of the channel and thecontainer.

In some embodiments, each container may have a body 849 a, 849 b and acap 848 a, 848 b. The container body may have a tubular shape. In someinstances, the container body may have a cylindrical portion. The bottomof the container may be flat, tapered, rounded, or any combinationthereof. The containers may comprise an open end and a closed end. Theopen end may be a top end of the container, which may be at the end ofthe container closer to one or more channel. The closed end may be abottom end of the container, which may be at the end of the containerfurther from one or more channel. There may be variations andalternatives to the embodiments described herein and that no singleembodiment should be construed to encompass the entire invention.

A support 830 may have one or more optical indicators, such as opticalwindows 832 a, 832 b. The optical windows may be positioned overportions of the channels 822 a, 822 b. The optical windows may providean indicator of whether a sample has reached and/or passed through theportion of the channels shown by the optical windows. This may be usefulto assess whether the sample has flowed sufficiently for the user topush the body into the sample collection device. In some instances, itmay be desirable for the sample to reach the second end of the channels,or to near the second end of the channels, before causing the channelsto enter into fluid communication with the containers. In someinstances, the sample may need to reach a certain portion of the channelbefore pushing the body in to bring the channels into fluidcommunication with the containers. The certain portion of the channelmay underlie the optical windows.

A base 840 may have one or more optical indicators, such as opticalwindows 842 a, 842 b. The optical windows may be positioned over thecontainers 846 a, 846 b. In some instances, the optical windows may bepositioned over the container bodies. The optical windows may provide anindicator of whether a sample has entered the containers. The opticalwindows may show how much sample has filled the containers. This may beuseful to assess whether a sufficient amount of sample has entered thecontainers. In some instances, it may be desirable for a particularamount of sample to enter the containers before removing the containersfrom fluid communication with the channels. A predetermined volume ofsample in the containers may be desired before removing a base of thedevice, thereby bringing the containers out of fluid communication withthe channels.

The containers and/or interfaces with the channels may have anycharacteristic or feature, such as those described elsewhere herein. Insome instances, a second end of the channel may penetrate a cap of thecontainer, thereby bringing the channel into fluid communication withthe container. In some instances, the channel may be withdrawn from thecontainer, and the cap of the container may form a fluid-tight seal,thereby permitting a fluid-tight environment within the container whenthe channel is brought out of fluid communication with the container.

One or more engagement assembly may be provided. The engagement assemblymay include a channel holder and/or a force-exerting component, such asa spring or elastic. The holder may keep the channel affixed to thebody. The holder may prevent the channel from sliding relative to thebody. The holder may optionally provide a support upon which aforce-exerting component, such as a spring, may rest.

In one example, the engagement assemblies may include a spring which mayexert a force so that the body is at its extended state, when the springis at its natural state. When the body is at its extended state, spacemay be provided between the containers 846 a, 846 b and the bottomportion of the sample body 820. The second ends of the channels may bein a position where they are not in fluid communication with theinteriors of the containers.

When the body is pressed in, the spring 852 may be compressed (see alsoFIGS. 9A-9C). The second ends of the channels may penetrate the caps ofthe containers. The second ends of the channels may enter the interiorof the container. In some instances, a force may be provided to drivethe fluid from the channels into the containers. For example, a pressuredifferential may be generated between the first and second ends of thechannels. A positive pressure may be provided at the first end 823 a,823 b of the channels and/or a negative pressure may be provided at thesecond end of the channels. The positive pressure may be positiverelative to the pressure at the second end of the channel, and/orambient air. The negative pressure may be negative relative to thepressure at the first end of the channel and/or ambient air. In oneexample, the containers 846 a and 846 b may each have a vacuum therein.When the second end of a channel penetrates a container, the negativepressure within the container may suck the sample into the container. Inalternative embodiments, the sample may enter the container driven bycapillary forces, gravity, or any other motive force. Optionally, theremay be single or multiple combinations of forces to fill the containerwith fluid.

In some instances, different types of motive forces may be used to drawthe sample into the channel, and from the channel into the container.For example, a capillary force may draw the sample into a channel, and apressure differential may drive the sample from the channel into thecontainer. Any combinations of motive forces may be used to draw sampleinto the channel and into the container.

Some time may elapse after a sample has been introduced to a channel fortraveling along the length of the channel. A user may introduce a sampleto the sample collection device and may wait for the sample to travelthe length of the channel. One or more optical indicator along thelength of the channel may be provided, which may indicate whether thesample has reached the end of the channel. In other embodiments, theuser may wait a predetermined amount of time before pushing in the body.The body may be pushed in after the user has determined the sample hastraveled a sufficient length of the channel and/or a sufficient amountof time has passed since the sample was introduced. The body may have aflat surface which may be easy for the user to push. In some instances,the flat surface may have a cross-sectional area that may be sufficientfor a user's fingers to press down on the body. After the body is pushedin, the channels may be brought into fluid communication with thecontainers, and sample may flow from the channel into the containers. Anoptical indicator may be provided so that a user may know when thecontainers have been filled.

Once the containers have been filled, they may be transferred to adesired location, using systems and methods described elsewhere herein.As previously described, the entire sample collection device may betransferred. In other embodiments, the base portion may be removablefrom the rest of the device. In one example, the base may be removedfrom the sample collection device, and the containers may be transferredalong with the base. Alternatively, the base may be removed from thesample collection device to provide access to the containers, and thecontainers may be removed from the device and transmitted

Referring now to FIGS. 9A-9C, examples of a sample collection device 900and method of use will now be described. In one nonlimiting example, thedevice may have a body 920, support 930, and base 940. The body 920,support 930, and base 940 may be movable relative to one another. Insome instances, the various components of the devices may be movableduring different stages of use. Examples of stages of use may includewhen the device is in an extended state, compressed state, and separatedstate.

FIG. 9A shows an example of the device 900 in an extended state. Thebody 920 may be extended relative to the support. Channels 922 a, 922 bconfigured to transport a sample may be affixed to the body. A first endof a channel may extend out from the body and/or the rest of the samplecollection device. A second end of the channel may be within and/orencompassed by a portion of the sample collection device. The channelmay be fluidically isolated from a respective container housed by thebase 940. The support 930 may be positioned between the body and base.The support may at least partially encompass a portion of the channel.In some instances, the support may encompass the second end of thechannel.

When in an extended state, the device may have an extended length. Thelength of the device may be from the bottom of the base to the first endof the channels. Alternatively, the length of the device may be measuredfrom the bottom of the base to the top of the body.

As seen in FIG. 9A, the device 900 may be in an extended state when thesample is introduced to the device. For example, a sample may becontacted by at least a first end of a channel. The sample may be drawninto the channel via capillary action or any other technique or motiveforce described herein. The forces may act alone or in combination todraw sample into the device. The device 900 may remain in an extendedstate while the sample is traversing the channel. The sample may fillthe entire length of the channel, a portion of the length of thechannel, or at least a minimum portion to meet a desired sampleacquisition volume.

FIG. 9B shows an example of the device 900 in a compressed state. Thebody 920 may be compressed relative to the support. The channels 922 a,922 b may be affixed to the body. The channels may be fluidiccommunication with their respective containers. When the device isbrought into a compressed state, a first channel may be brought intofluid communication with an interior of a first container, and a secondchannel may be brought into fluid communication with an interior of asecond container.

By way of nonlimiting example, a user may push the body 920 toward thesupport 930 (or vice versa) to bring the device into a compressed state.The relative motion between parts may involve movement of both pieces.Optionally, movement may involve moving only one of them. In the presentexample, the body 920 may be pushed all the way to the support 930 sothat no interior portion of the body is exposed and/or a lip of the bodycontacts the support. Any stop mechanism may be used that may be engagedwhen the device is completely compressed. Alternatively, the body mayonly be partially pushed. For example, a portion of the interior portionof the body may be exposed. The support may be positioned between thebody and base. The support may at least partially encompass a portion ofthe channel. In some instances, the second end of the channel may extendbeyond the support of the device.

When in a compressed state, it should be understood that the device 900may have a compressed length. The length of the device 900 may be fromthe bottom of the base to the first end of the channels. Alternatively,the length of the device may be measured from the bottom of the base tothe top of the body. The compressed length of the device may be lessthan the extended length of the device. In some embodiments, thecompressed length of the device may be at least about 0.1 cm, 0.5 cm,1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, or 5.0 less thanthe extended length of the device. The compressed length of the devicemay be less than or equal to about 50%, 60%, 70%, 75%, 80%, 85%, 90%,95%, 97% or 99% of the extended length of the device.

One or more engagement assemblies may be provided with the device 900.The engagement assembly may include a channel holder 950 and/or aforce-exerting component, such as a spring 952 or elastic. The holder950 may keep the adaptor channel 954 affixed to the support. As will bedescribed elsewhere herein, the adaptor channel 954 may be formedintegrally with the collection channel or may be a discrete element thatmay be a stand-alone piece, part of the collection channel, or part ofthe container. In one embodiment, the holder 950 may prevent the adaptorchannel 954 from sliding relative to the support. The holder 950 mayoptionally provide a support upon which a force-exerting component, suchas a spring, may rest. The force-exerting component, such as a springmay be in a compressed state when the device is in a compressed state.The spring may exert a force on the body of the device when the deviceis in a compressed state.

The device may be in a compressed state when the sample is transferredfrom the channels to the respective containers. In some examples, thetransfer may occur via pressure differential between the channels andthe interiors of the containers, when they are brought into fluidiccommunication. For example, a second end of the channel may be broughtinto fluidic communication with the interior of the container. Thecontainer may have a vacuum and/or negative pressure therein. The samplemay be sucked into the container when the channel is brought intofluidic communication with the vacu-container. The device may remain ina compressed state while the sample is being transferred to thecontainer. The sample may fill the entire container or a portion of thecontainer. The entirety of the sample (and/or greater than 90%, 95%,97%, 98%, 99%, 99.5% or 99.9% of the sample) from the channels may betransferred to the containers. Alternatively, only a portion of thesample from the channels may be transferred to the containers.

Referring now to FIG. 9C, an example of a device 900 in a separatedstate will now be described. The base 940 may be separated from the restof the device 900. The body 920 may be extended or compressed relativeto the support 930. In one example, the extended state may be thenatural state, so that when the force is no longer exerted on the bodyby the user, the body may extend back to the extended state. Thechannels 922 a, 922 b may be affixed to the body.

When the device 900 is in a separated state, the base 940 may beseparated from the support 930 of the device. The channels 922 a, 922 bmay be removed from fluidic communication with their respectivecontainers 946 a, 946 b. When the device 900 is brought into theseparated state, a first channel may be brought out of fluidcommunication with an interior of a first container, and a secondchannel may be brought out of fluid communication with an interior of asecond container. This may occur sequentially or simultaneously. Whenthe channels are removed from the containers, the containers may assumea sealed state to prevent undesired material from entering thecontainers. In some embodiments, the containers may be fluid-tight afterremoval of the channels. Optionally, the containers may be gas-tightafter removal of the channels.

A user may separate the base 940 from the support 930 to bring thedevice into a separated state to remove the containers therein. In someembodiments, the base may be separated from the support or vice versa.Separating the base from the support may expose the containers 946 a,946 b that are supported by the base. The containers may be press-fit orotherwise held within the base. The containers 946 a, 946 b may beremovable from the base. By way of non-limiting example, removing thecontainers 946 a, 946 b allows them to be placed with other containersin a climate controlled container for transport to an analysis site.Optionally, the containers 946 a, 946 b may be removed to allow forpre-treatment such as but not limited to centrifugation prior to beingsent on for processing at an analysis site. Alternatively, thecontainers 946 a, 946 b may remain with the base.

FIGS. 10A-10B provide additional views of a sample collection device1000 in a separated state. When in a separated state, the base 1040 maybe separated (partially or completely) from the support 1030 and/or body1020 of the device. This allows for the removal of the containers 1046 aand 1046 b through the end of base 1040 previously not externallyexposed when the device 1000 was not in a separate state.

When the device is in a separated state, one or more channels 1022 a,1022 b may be fluidically isolated from one or more containers 1046 a,1046 b housed by the base 1040. The containers may be fluidically sealedfrom their environment. The containers may contain sample therein, thathad been transported through the collection channels, reached a minimumfill level, and then substantially fully deposited into the respectivecontainers. The base 1040 may include one or more optical indicator 1046a, 1046 b. The optical indicator may show a portion of the containerstherein such that the device 1000 is not moved into the separate stateuntil a minimum fill level has been reached in the containers. By way ofnon-limiting example, the containers may have an optically transmissivematerial that may permit a user to view the sample within the containersfrom outside the base.

In some embodiments, the base 1040 may encompass at least a portion ofthe containers. The base may have a hollow interior and wallssurrounding the hollow interior. The base may have one or more shapedfeature that may support the containers. The containers may be providedwithin the hollow interior. The walls may surround the container. Thebase may have an open top though which the containers may be exposed.The containers may or may not be removed through the open top.

Collection Device with Multiple Collection Channels

Referring now to FIGS. 11A-11F, a still further embodiment as describedherein will now be described. This embodiment provides a bodily fluidsample collection device 1100 for use in collecting a fluid sample thatmay be pooled or otherwise formed on a surface, such as but not limitedto the skin or other target area of a subject. Although this embodimentshows a device body which defines at least two collection channels ofdifferent volumes therein, it should be understood that devices withfewer or greater numbers of collection channels are not excluded.Embodiments where the same collection volume is used for one or more thechannels are also not excluded. There may be variations and alternativesto the embodiments described herein and that no single embodiment shouldbe construed to encompass the entire invention.

FIG. 11A shows a perspective view of one embodiment of a bodily fluidsample collection device 1100 with a distal end 1102 configured toengage a fluid sample on a surface. In this embodiment, the distal end1102 may have a configuration designed to better engage a droplet orpool of bodily fluid or sample formed on a surface. Some embodiments, inaddition to a desired shape, may also have surface treatments at thedistal end 1102, such as but not limited to, chemical treatments,texturing, surface features, or coatings to encourage fluid flow towardsthe one or more openings 1104 and 1106 on the distal end 1102 leading tothe channels in the device 1100.

As seen in FIG. 11A, this embodiment of the sample collection device1100 has two openings 1104 and 1106 for receiving the sample fluid. Itshould be understood that some embodiments may have more than twoopenings at the distal end. Some embodiments may only have one openingat the distal end. Optionally, some embodiments may have additionalopenings along a side or other surfaces leading away from the distal end1102 of the device 1100. The openings 1104 and 1106 may have anycross-sectional shape. In some non-limiting examples, the openings mayhave a circular, elliptical, triangular, quadrilateral (e.g., square,rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or anyother cross-sectional shape. The cross-sectional shape may remain thesame or may vary along the length of the collection device body. In someinstances, the openings may have a cross-sectional area of less than orequal to about 2 mm², 1.5 mm², 1 mm², 0.8 mm², 0.5 mm², 0.3 mm², or 0.1mm². Some embodiments have the opening be the same shape. Others may usedifferent shapes for the one or more openings.

The sample fill portion 1120 which may be the body of the samplecollection device 1100 may be formed from a transparent and/ortranslucent material that may enable a user to see if a sample hasentered sample collection channel(s) (see FIG. 11B) in the sample fillportion 1120. In some embodiments, the entire sample fill portion 1120is transparent or translucent. Alternatively, some embodiments may onlyhave all areas over the channel or only select portions of the channelor sample fill portion 1120 be transparent or translucent to allow auser to visualize the filling of sample into the sample collectiondevice 1100. Optionally, the sample fill portion is made of an opaquematerial but has an opening or a window to allow for visualization offill level therein. The device 1100 may further include one or morevisualization windows 1112 and 1114 to allow a user to see when adesired fill level has been reached. The visualization window may beformed from a transparent and/or translucent material. Alternatively,the visualization window may be an opening without any material therein.Additional visualization windows can also be used to determine of all ofthe fluid in the collection channels have been emptied into thecontainers 1146 a and 1146 b (see FIG. 11B).

FIG. 11A also shows that some embodiments of support 1130 may haveoptical windows 1132 and 1134 which are positioned to show fill levelsin the containers 1146 a and 1146 b to show if the containers in base1140 have been moved into position to receive sample fluid. Optionally,the windows 1132 and 1134 may be cutouts that act as guides for the snapfeature of based in order to define the start and end positions duringactivation. It should be understood that the base can be configured tohold one or more sample containers. By way of example and notlimitation, the entire base 1140 can be removed from the samplecollection device before or after sample fill. The base 1140 can be usedas holder to retain the sample containers therein during transport, andin such an embodiment, the base 1140 along with the sample containerswould be loaded into a shipping tray or other holder for transport.Alternatively, some embodiments may remove the sample containers fromthe base 1140 and then transport the containers without the base 1140holding them.

FIG. 11B shows a cross-sectional view along section lines B-B of theembodiment shown in FIG. 11C. FIG. 11B shows the channels 1126 and 1128in the portion 1120. The sample fill portion 1120 may be formed from twoor more pieces which join together to define the portion 1120. Some maydefine the channels in one piece and then have another piece which matesto the first piece to define an opposing or top wall surface of thechannel. In terms of manufacturing, this allows one piece to havechannels molded or otherwise formed into the body and the opposing piecewill mate to act as a cover for the channels or may also includeportions of the channel too. The channels 1126 and 1128 may be formedonly in portion 1120 or may also extend into support 1130 that hasfeatures to connect with the containers held in base or carrier 1140.Some embodiments may integrally form portions 1120 and 1130 together.Support 1130 may also be configured to hold adapter channel 1150 whichwill fluidically connect the channels 1126 and 1128 with theirrespective containers 1146 a and 1146 b.

Although these embodiments herein are described using two channels andtwo containers, it should be understood that other numbers of channelsand containers are not excluded. Some embodiments may have more channelsthan containers, wherein some channels will couple to the samecontainer. Some embodiments may have more containers than channels, inwhich case multiple containers may operably couple to the same channel.

As seen in FIG. 11B, the channels 1126 and 1128 may be of differentsizes. This allows for different fluid volumes to be collected in eachchannel before they are simultaneously transferred into the containers1146 a and 1146 b. Optionally, some embodiments may have the channels1126 and 1128 sized to contain the same volume of fluid. In someembodiments, the fluid pathway of the channels 1126 and 1128 are shapedand/or angled so that openings near the distal end 1102 are closertogether than proximal ends, which may be further apart to align themfor entry into the containers 1146 a and 1146 b. There may be variationsand alternatives to the embodiments described herein and that no singleembodiment should be construed to encompass the entire invention.

FIG. 11B also shows that some embodiments may use needles for theadapter channels 1150 and 1152 in the body 1130 which are incommunication with the channels 1126 and 1128. The needles each has achannel to allow for fluid to pass therethrough from the collectionchannels 1126 and 1128 to the ends of the needles. As seen in FIG. 11B,the containers 1146 a and 1146 b in the base 1140 are slidable relativeto the support 1130 as indicated by arrow 1156. Relative motion betweensupport 1130 and base 1140 can close the gap 1160. Closing the gap 1160brings the adapter channels 1150 into the cap 1148 a of the container1146 a until there is fluid communication between the interior ofcontainer 1146 a and the collection channel 1126. At that time, motiveforce in the form will then move fluid in the channel 1126 into thecontainer 1146 a.

By way of example and not limitation, any combinations of motive forcesmay be used to draw sample into the container. Some embodiment may usepull from vacuum in the containers 1146 a to draw sample into thecontainer. Some may use pushing force from external pressure to movefluid into the container. Some embodiments may use both. Some may relyon capillary and/or gravity. In some embodiments, the motive force(s)used to draw sample into the channel is different from motive force(s)used to draw sample into the container. In some alternative embodiments,the motive force(s) may be the same for each stage. In some embodiments,the motive force(s) are applied sequentially or at defined time periods.By way of non-limiting example, motive force(s) to draw sample into thecontainer is not applied until the at least one channel has reach aminimum fill level. Optionally, motive force(s) to draw sample into thecontainer is not applied until the at least two channels have each reacha minimum fill level for that channel. Optionally, motive force(s) todraw sample into the container is not applied until all channels haveeach reach a minimum fill level for that channel. In some embodiments,the motive force(s) are applied simultaneously. This features recitedmay be applicable to any of the embodiments herein.

Referring now to FIG. 11E, an enlarged cross-sectional view of thedevice 1100 is shown. This embodiment shows that the support 1130 has alip portion 1136 sized to extend over the adapter channels 1150 and 1152in an amount sufficient to prevent a user from inserting a finger intothe gap 1160 and piercing the finger on one of the needle.

Additionally, as shown in FIGS. 11B and 11E, the present embodiment hasat least two channels in the sample collection device 1100. This allowsfor each of the channels 1128 and 1126 to each introduce a differentmaterial into the sample. By way of non-limiting example, if the sampleis whole blood, one channel can introduce heparin into the blood whileanother channel introduces ethylenediaminetetraacetic acid (EDTA). Notonly do these anti-coagulants prevent premature clogging of the channelsduring fill, but also introduce anti-coagulant into the whole blood inpreparation for transport in the containers 1146 a and 1146 b.Optionally, the channel(s) may also be plasma coated in addition to orin place of the anti-coagulants. The plasma coating can reduce the flowresistance of the body fluid sample in the channels. Such a coating canbe applied in patterns such as but not limited to strips, rings, orother patterns along with any other coating(s) to be used in thechannels.

Optionally, there is sufficient quantity of anti-coagulant in therespective channel such that the sample fluid will contain a desiredlevel of anti-coagulant in the sample fluid after only a single pass ofthe fluid through the channel. In traditional blood vials, the bloodsample does not contain anti-coagulant until it enters the vial and oncein the vial, the technician typically repeatedly tilts, shakes, and/oragitates the vial to enable mixing of anti-coagulant in the vials. Inthe present embodiment, the sample fluid will contain anti-coagulantprior to entering the sample container and it will do so without havingto repeatedly tilt or agitate the sample collection device. In theembodiment herein, a single pass provides enough time and sufficientconcentration of additive such as anti-coagulant into the sample fluid.In one embodiment, an EDTA channel has a volume of 54 uL coated by 200mg/mL EDTA; a channel for Heparin has a volume of about 22 uL coated by250 units/mL Heparin. In another embodiment, the EDTA channel has avolume of 70 uL coated by 300 mg/mL EDTA; the channel for Heparin has avolume of about 30 uL and is coated by 250 units/mL Heparin. By way ofnon-limiting example, a channel of volume from 50 to 70 uL can be coatedby EDTA in the range from about 200 to 300 mg/mL EDTA. Optionally, achannel of volume from 70 to 100 uL can be coated by EDTA in the rangefrom about 300 to 450 mg/mL EDTA. Optionally, a channel of volume from20 to 30 uL can be coated by Heparin in the range from 250 units/mLHeparin. By way of example, the material may be solution coated onto thetarget surface for less than 1 hour and then dried overnight. There maybe variations and alternatives to the embodiments described herein andthat no single embodiment should be construed to encompass the entireinvention.

Referring now to FIG. 11G, a still further embodiment will now bedescribed. The embodiment of FIG. 11G shows that at a distal end 1202 ofthe sample collection device 1200, instead of having one opening 1204for each of the channels, the sample collection device 1200 merges twoor more of the channels into a single channel. The embodiment of FIG.11G shows that there is common channel portion prior to the split of thecommon channel into to a plurality of separate channels. As will bedescribed below in FIG. 11I, optionally, there may be back flowpreventer such as but not limited to a vent positioned along theseparate channel to reduce the possibility of drawing sample from onechannel into another channel during filling and/or extraction of samplefrom the channels into the sample container(s).

As seen in FIG. 11H, this use of common flow paths can result in areduced number of openings on the exterior of the sample collectiondevice 1200, which may make it align the opening 1204 to engage thebodily fluid sample. It may also increase the capillary force fordrawing bodily fluid sample into the sample collection device 1200 byhaving more capillaries pulling on the same channel where the bodilyfluid sample enters the collection device.

Referring now to FIG. 11I, a cross-sectional view of select componentsof a sample collection device will now be described. FIG. 11I shows thatthe sample collection device can have two channels 1182 and 1184 thathave a common portion 1186 leading towards an inlet opening on thedevice. In some embodiments, the common portion 1186 is a continuationof one of the channels 1182 or 1184 in terms of size, shape, and/ororientation. Optionally, the common portion 1186 is not of the samesize, shape, and/or orientation of any of the channels 1182, 1184, orany other channel that may be in fluid communication with the commonportion 1186. FIG. 11I shows that in one non-limiting example, there maybe a step at the interface 1188 between the channel 1182 and 1184. Thisinterface 1188 may be configured to ensure flow into both of thechannels so that they will both reach a full fill. In one embodiment,the interface 1188 has a size greater than the channel 1182 leading awayfrom the interface 1188. Although other sizes are not excluded, thisinterface 1188 of greater size may ensure that sufficient flow willenter the channel 1182, which in the present embodiment, has a smallerdiameter and reduced volume relative to the channel 1184. There may bevariations and alternatives to the embodiments described herein and thatno single embodiment should be construed to encompass the entireinvention.

FIG. 11I also shows that there may be vents 1190 and 1192 that can beused to prevent cross-flow between channels, particularly when sample isbeing transferred into the sample containers. In one embodiment, thevents 1190 and 1192 are open at all times. In another embodiment, thevents 1190 and 1192 may be open only at select times, such as but notlimited to after the channels 1182 and 1184 are filled or substantiallyfilled. Some embodiments may use a dissolvable material the plugs thevents 1190 and 1192 until they are in contact with sample fluid.Optionally, some embodiments may use a slidable covers one or more ofthe vents 1190 and 1192 such that they are only opened at times selectedby the user. In one embodiment, the covers are linked to the samplecontainers such that movement of the sample containers to move intofluid communication with the channels will also open one or more vents1190 and 1192 to reduce the risk of cross-flow between channels.Optionally, other anti-crossflow mechanisms such as valves, gates, orplugs can also be used to prevent fluid transfer between channels 1190and 1192.

FIG. 11I also shows that there may be anti-leakage devices 1194positioned over the adapters 1150 and 1152. In this embodiment, theanti-leakage devices 1194 are frits which may be slidably moved from afirst position where they prevent sample from leaking out from theadapters 1150 and 1152 to a second position wherein they allow theadapters to deliver fluid into the sample containers. In onenon-limiting example, the anti-leakage devices 1194 will slide when thenare engaged by the sample containers or the housing that holds thesample containers. The movement of the sample containers or the housingin this non-limiting example shows that the movement of those elementswill also cause movement of the anti-leakage devices 1194.

Integrated Tissue Penetrating Member

Referring now to FIG. 11J, yet another embodiment of a sample collectiondevice will now be described. This sample collection device 1210comprises features similar to that shown in FIG. 11G, except that itfurther includes a tissue penetrating member 1212 that is mounted to thesample collection device 1210. An actuation mechanism 1214 such as butnot limited to a spring actuator can be used to launch the tissuepenetrating member. FIG. 11J shows the actuation mechanism 1214 in aresting state and that it can be a spring that can be compressed tolaunch a tissue penetrating member 1212 towards target tissue. Thetissue penetrating member 1212 can be housed inside a housing 1216(shown in phantom). In one embodiment, the housing 1216 comprises aportion that can be peeled back, pierced, released or otherwise openedto allow the tissue penetrating member 1212 to exit the housing but alsomaintain sterility of the tissue penetrating member 1212 prior to itsuse. In some embodiments, the portion may be a foil, a cap, a polymerlayer, or the like. There may be variations and alternatives to theembodiments described herein and that no single embodiment should beconstrued to encompass the entire invention.

In one embodiment, the tissue penetrating member 1212 path can becontrolled along both the “normal” (i.e., forward direction of thetissue penetrating member) and “orthogonal” (i.e., perpendicular to mainmotion vector) of the trajectory. Some embodiments may have not have ahard stop or bang stop at the deepest point of penetration (i.e., returnpoint), which is the main cause for spontaneous pain. Some embodimentsmay use a cushion, a cam pathway, or other non-hardstop mechanism toprevent pain associated with the shockwave of a sudden stop. Such ashockwave is detrimental even if the tissue penetrating membersuccessfully avoids hitting nerves near the wound location as theshockwave can activate such nerves even if direct contact was avoided.Optionally, some embodiments may have the tissue penetrating memberfollow a non jitter path, to prevent a rough wound channel (residualpain). This may be achieved in some embodiments through tightertolerance in any guide pathway used with tissue penetrating member or apin associated with the tissue penetrating member. This may be a nonjitter path when penetrating the tissue. Optionally, this may be a nonjitter path for the tissue penetrating member both outside the tissueand when it is inside the tissue. This can reduce overall motion“wobble” of the tissue penetrating member that may cause residual pain,long-lasting trauma, and scarring.

Some embodiments may have a controlled outbound speed to prevent slowand delayed wound closure and after bleeding. By way of nonlimitingexample, the controlled outbound speed of the tissue penetrating membercan be controlled by mechanical mechanisms such as but not limited camsor higher friction materials.

Some embodiments may also include anti-bouncing mechanisms to preventunintended re-lancings that can be associated with an uncontrolledtissue penetrating member that rebounds into the tissue after initialwound creation. Some embodiments herein may have “parking” mechanisms orlock-out mechanisms that will engage the tissue penetrating member orits attachments to prevent re-entry of the tissue penetrating memberonce it has retracted out of the tissue or some other desired distance.

The abruptness with which the lancet comes to a stop in the skin atmaximum depth, before it starts its outbound motion and returning to itsstarting position, is an inherent issue of this design. With the lancetat its deepest point of penetration, the greatest amount of force isapplied to the skin. The drive mechanism simply bounces off the end ofthe device like a ball bounces back from the floor. The lancet, comingto an abrupt stop at the end point of its inbound motion, sends ashockwave into the skin, causing many pain receptors in the vicinity ofthe lancet to fire, even though they are not directly struck. Thisamplifies spontaneous pain substantially.

As mentioned, instead of simple spring actuated tissue penetratingmembers, some embodiments may use mechanical cam actuation. Devices withcam-actuation design can minimize “hard stopping” of the tissuepenetrating member. A cam mechanism is usually spring driven andgenerally offers a better guided actuation. The trajectory of the tissuepenetrating member is tightly controlled through a guided path of thetissue penetrating member holder via a pin riding in a cam. The cammechanism allows for a predetermined speed profile with a softer returnand distinct speed control for the tissue penetrating member outboundtrajectory. This mechanism also effectively avoids a bounce back of thelancet into the skin when the mechanism reaches its motion end point. Inaddition, the mechanical oscillation (or jitter/wobble) of the lancepath in both directions is reduced when fired in air. Some embodimentsherein may also minimize any mechanical wobble of the drive mechanism(e.g., due to uneven or rough cam slots) to prevent transfer of suchdrive mechanism wobble directly into the tissue because of its “forcedmotion profile.”

Optionally, some embodiments may use electronic actuation through anelectronically controlled drive mechanism. This technology uses aminiaturized electronic motor (e.g., voice coil, solenoid) coupled witha very accurate position sensor, moving the tissue penetrating memberinto and out of the skin with precisely controlled motion and velocity.Following rapid entry, the device decelerates the tissue penetratingmember to an exact, preset depth to return smoothly, without jitter, andrelatively slowly. This allows quick wound closure and avoids long-termtrauma. With this device, the force required to penetrate the lancetinto the skin is controlled while the tissue penetrating member isprogressing. The benefit of tightly controlling the tissue penetratingmember actuation “profile” is a reproducible painless lancing thatyields a sufficient and consistent blood sample for testing.

In terms of puncture site creation for blood sample extraction, it maybe desirable to elect the appropriate puncture site on one of thepatient's fingers (ring or middle) on their non-dominant hand. Thepuncture sites may be on the sides of the tips of the fingers. In onenonlimiting example, it may be desirable to hold the hand warmer stripagainst the patient's selected finger for 15 seconds. This will increaseblood flow to the finger. Wipe the side tip of the selected finger withan alcohol wipe, being sure to wipe the selected puncture site. Waituntil the skin is completely dry. Do not dry with gauze or blow air onthe fingertip.

After a puncture has been formed, hold the finger downward, below thepatient's waist, in order to allow blood to flow. Massage the fingerlightly from base to tip until a blood drop has formed. Carefully fillthe blood collection device by touching the tip of the device to thebead of blood on the finger. Make sure the device is completely filled.Once the blood collection device is filled, press the bleeding area ofthe finger against the gauze pad on the table. Transfer the blood sampleinto the collection containers. Place a band-aid over the finger. Placethe containers with the sample into the shipping box inside therefrigerator. Discard all supplies in the biohazard sharps container.All supplies are single-use only.

If enough blood is not obtained from the first puncture, carefully placethe blood collection device on the table surface, ensuring that thedevice remains horizontal. Place a band-aid over the finger that waspunctured. Select the appropriate puncture site on a different finger onthe patient's same hand. If the ring finger was punctured first, choosea new puncture site on the middle finger, and vice versa. Hold the handwarmer strip against the patient's selected finger for 60 seconds. Thiswill increase blood flow to the finger. These techniques for bloodcollection using a sample collection device such as any of those hereincan enable sufficient sample collection of capillary blood for use inlaboratory testing at Clinical Laboratory Improvement Amendments (CLIA)certified facility and/or standards.

Referring now to FIG. 11K, yet another embodiment of a sample collectiondevice 1220 will now be described. In this embodiment, the tissuepenetrating member 1222 may be mounted at an angled relative to thesample collection device 1220. This angled configuration allows fortissue penetrating member to create a wound at a location that alignswith sample acquisition opening(s) 1103 and 1105. Although a standardspring-launched actuator is shown as the drive mechanism 1224 for thetissue penetrating member 1222, it should be understood that cam and/orelectrical drive systems may also be used in place of or in combinationwith the spring launcher. When the drive mechanism 1224 is a spring, thespring can be compressed to move the tissue penetrating member 1222 to alaunch position and the released to penetrate into the target tissue.FIG. 11K shows the tissue penetrating member 1222 in a resting position.Although the figures show a spring for the drive mechanism 1224, itshould be understood that other drive mechanism suitable for use inlaunching a tissue penetrating member to create a healable wound on asubject are not excluded. There may be variations and alternatives tothe embodiments described herein and that no single embodiment should beconstrued to encompass the entire invention.

A housing 1226, similar to that described for housing 1216, may beformed around the tissue penetrating member 1222. Although FIG. 11Kshows two tissue penetrating members 1222 mounted on the samplecollection device, it should be understood that devices with more orfewer tissue penetrating members are not excluded. For example, someembodiments may have only one tissue penetrating member 1222 mounted tothe sample collection device 1220. There may be variations andalternatives to the embodiments described herein and that no singleembodiment should be construed to encompass the entire invention.

Referring now to FIG. 11L, another embodiment of a sample collectiondevice 1230 will now be described. This embodiment shows that the tissuepenetrating member 1232 is contained within the sample collection device1230 and as seen in FIG. 11L, it is actually co-axially aligned with thecentral axis of the sample collection device. This positions the tissuepenetrating member 1232 to extend outward from the sample collectiondevice 1230 at a location close to where openings 1103 and 1105 arepositioned on the sample collection device 1230. Of course, deviceshaving more or fewer openings are not excluded and the embodiment ofFIG. 11L is exemplary and non-limiting. FIG. 11L shows that in oneembodiment of the sample collection device, a firing button 1234 may bemounted on the sample collection device 1230. Optionally, someembodiments may have the shaped front end 1236 function as the actuationbutton, wherein upon pressing the tissue against the front end 1236 to acertain depth and/or certain pressure, the tissue penetrating memberwill be actuated.

Once fired, the tissue penetrating member 1232 moves as indicated byarrow 1233. In some embodiments, the tissue penetrating member 1232 isfully contained inside the sample collection device 1230 prior toactuation. Some embodiments may have a visual indicator 1235 on thedevice 1230 to help guide the user on where the tissue penetratingmember 1232 will exit the device and where approximately the wound willbe formed.

In this non-limiting example, the entire device 1230 may be in a sterilepouch or package that is only opened before the device 1230 is used. Inthis manner, sterile conditions are maintained for the tissuepenetrating member and the collection device prior to use. This externalsterile pouch or package is also applicable to any of the otherembodiments herein. FIG. 11L also shows that a shaped front end 1236(shown in phantom) that can be integrally formed or separately attachedto the sample collection device 1230. This shaped front end 1236 canprovide suction to draw sample fluid into the sample collection device1230. Optionally, the shaped front end 1236 can be used to stretch thetarget tissue and/or force it into the shaped front end to applypressure to increase sample fluid yield from wound formed by the tissuepenetrating member 1232. It should be understood that any of theembodiments herein can be adapted to have a shaped front end 1236.Optionally, the shaped front end may have select hydrophobic area(s) todirect sample fluid to towards one or more collection areas on the frontend. Optionally, the shaped front end may have select hydrophilicarea(s) to direct sample fluid to towards one or more collection areason the front end.

Referring now to FIG. 11M, yet another embodiment of a sample collectiondevice will now be described. This embodiment is similar to that of FIG.11L except that, instead of single tissue penetrating member such as alancet, the embodiment of FIG. 11L uses a plurality of tissuepenetrating members 1242. In one embodiment, these tissue penetratingmembers are microneedles 1242 that are of reduced diameter as comparedto traditional lancets. A plurality of microneedles 1242 can besimultaneously actuated for device 1240 and create multiple wound siteson the tissue. The spacing of the microneedles 1242 can result in morecapillary loops being pierced and more channels being available forblood to reach the tissue surface. This also allows for a more “square”penetration profile as compared to a lancet which has a pointed tip anda tapered profile. This may enable the microneedles 1242 to engage morecapillary loops over a larger area without penetrating too deep intodeeper tissue layers that are more densely populated with nerve endings.

Referring now to FIGS. 11N and 11O, a still further embodiment of asample collection device will now be described. In the embodiment shownin these figures, the sample collection device 1100 may be mountedangled to a dedicated wound creation device 1250 that has a tissuepenetrating member 1252 configured to extend outward from the device1250. The sample collection device 1100, which may optionally beconfigured to have a shaped front end 1236 (with or without an openingto accommodate the tissue penetrating member 1252), can be removablymounted to the wound creation device 1250. Optionally, the samplecollection device 1100 may be flat mounted to the device 1250.Optionally, there may be a shaped cut-out on device 1250 for press-fitholding the sample collection device 1100. It should be understood thatother techniques for removably mounting the sample collection device1100 are not excluded. This de-coupling of the collection device and thewound creation device allows for the use of a more sophisticated,possible non-disposable wound creation device 1250 that can create amore controlled, reduced-pain wound creation experience.

FIG. 11O shows that the sample collection device 1100 can be aligned tobe more or less horizontal to be neutral with regards to gravity effectson the sample collection. Other mounting configurations of device 1100to would creation device 1250 are not excluded.

Referring now to FIGS. 11P to 11R, still further embodiments of varioussample collection devices will now be described. FIG. 11P shows a samplecollection device 1240 where a shaped front end 1236 may be used withthe device 1240. This shaped front end 1236 is similar to thatpreviously described. A vacuum source 1270 can be used to assist indrawing bodily fluid sample into the device 1240. The vacuum source 1270may be linked to the body of device 1240 and/or to the shaped front end1236. It should be understood that any of the embodiments described inthis disclosure can be adapted for use with a sample acquisition assistdevice such as but not limited to a vacuum source 1270.

FIG. 11Q shows yet another embodiment of a sample collection device.This embodiment uses a pipette system having a tip 1280 for collectingsample fluid. The tip may include a coaxially mounted tissue penetratingmember 1282. Optionally, a side mount or angled tissue penetratingmember 1284 is shown to create the wound at the target site. The pipettesystem with tip 1280 can apply vacuum to pull sample fluid from thesubject. Optionally, a shaped front end 1236 may be used with the tip1280 to assist in skin stretching or tissue reshaping at the targetsite.

FIG. 11R shows that some embodiments may use a diaphragm 1291 linkedactuation mechanism to create a vacuum for drawing blood sample. Thislinkage allows for the diaphragm to create a vacuum on the return strokeof the tissue penetrating member 1292 from the target site. In oneembodiment, the tissue penetrating members 1292 are microneedles. Theactuation of the tissue penetrating members as indicated by arrows 1294launches the tissue penetrating members 1292 and on the return path,creates the vacuum due to the motion of the diaphragm linked to themotion of the tissue penetrating member 1292. One or more containers1296 can be coupled to hold fluid collected by the device 1290. Someembodiments may have only one container 1296. Some embodiments may haveone set of containers 1296. Some embodiments may have multiple sets ofcontainers 1296. Some embodiments may be mounted externally on device1290. Some embodiments may be mounted internally in device 1290. Theremay be variations and alternatives to the embodiments described hereinand that no single embodiment should be construed to encompass theentire invention.

Vertical Outflow Restrictors

FIG. 11E also more clearly shows that there are sleeves 1170 around theadapter 1150 and 1152. Although only shown in FIGS. 11A-11F, it shouldbe understood that sleeves with or without vents may be configured foruse with any of the embodiments contemplated herein. As seen in theembodiment of FIG. 11E, the channels may be defined by needles. Thesesleeves 1170 prevent premature flow of fluid sample out from the adapterchannels 1150 and 1152 before the containers 1146 a and 1146 b engagethe needles. Because of the low volumes of sample fluid being acquired,preventing premature flow reduces the amount of fluid loss associatedwith transfer of fluid from the channels to the containers. In oneembodiment, the sleeves 1170 can minimize that fluid loss by providing asleeve that is liquid tight, but not air tight. If the sleeve wereairtight, it may prevent the capillary action of the channels fromworking properly. Optionally, some embodiments may locate vents near thebase of the needle, away from the tip, such that the sleeve can containthe sample at locations away from the vents.

FIG. 11F shows that in an exemplary embodiment, the sleeve 1170 isconfigured to have an opening 1180 through the sleeve. This provides animproved embodiment over traditional sleeves which are typically looselyfitted over a needle. Because of the loose fit, in traditional sleeves,there is sleeve space in the tip and in side wall space between theneedle and the sleeve within which fluid sample can accumulate. Althougha sleeve of this design can help prevent greater loss of fluid byrestricting the loss to a defined amount as compared to a needle withouta sleeve which can lose fluid continuously, the fluid accumulating inthe sleeve area along the tip and side wall is still lost and notcollected by the containers 1146 a or 1146 b. The sleeve 1170 may alsoinclude a narrowed area 1176 to facilitate engagement of the sleeveagainst the device providing fluid communication with the channels 1126and 1128, such as but not limited to the needle, probe, tube, channel,or other adapter channel 1150.

In the embodiment of FIG. 11F, the opening 1180 is sized based oncalculations which are sufficient to withstand fluid pressure associatedwith the flow from the capillary action of the channels in sample fillportion 1120. This forces allows the opening 1180 to be there to ventair from the channel but also prevent fluid from exiting the sleeveuntil the containers 1146 a and 1146 b are pushed to engage the adapterchannels 1150 and 1152. Because of the vent effect created by theopening 1180, the side wall and other areas of the sleeve can be made tomuch more tightly engage the needle than in traditional sleeves. Thisreduces the gap space between the needle and the sleeve and thusminimizes the amount of fluid that can be lost as compared to sleeveswithout a vent hole which have a much greater gap space due to thelooseness of the fit. Additionally, the opening 1180 can also be sizedsuch once fluid reaches the opening, that it provides enough resistanceso that flow out from the channel or needle is also stopped so that hereis minimal fluid loss in any gap between the sleeve and the needle tip.

The calculations for sizing the opening are as shown in FIG. 12. Thedesire is to balance the forces such that there is sufficientleak-prevention force associated with the hydrophobic material definingthe vent to contain outflow of sample fluid outside of the sleeve. InFIG. 12, the side walls of the sleeve 1170 may be in direct contact withthe needle or in some embodiments, there may be a gap along the sidewallwith the sleeve. In one embodiment, the sleeve 1170 comprises ahydrophobic material such as but not limited to thermoplastic elastomer(TPE), butyl rubber, silicone, or other hydrophobic material. In oneembodiment, the thickness of the sleeve will also determine the lengthof the side walls of the opening or vent 1180 in the sleeve 1170.

The opening 1180 may be located at one or more positions along thesleeve 1170. Some may have it as shown in FIG. 12. Alternatively, someembodiments may have the opening 1180 on a side wall of the sleeve.Other locations are not excluded. Optionally, the sleeve 1170 may havemultiple openings through the sleeve, but configured such that fluiddoes not exit from the sleeve and resistance from the openings issufficient to prevent additional outflow from the channel until thecontainers 1146 a or 1146 b are engaged and in fluid communication withthe channels.

With regards to how the device 1100 is used to collect a sample, in onetechnique, the sample collection device 1100 is held to engage thetarget bodily fluid and is held in place until a desired fill level isreached. During this time, the device 1100 may be held horizontally tominimize gravitational force that would need to be overcome if thedevice 1100 were held more vertically. After a fill level is reached,the device 1100 may either be disengaged from the target fluid and thencontainers 1146 a and 1146 b engaged to draw collected fluid into thecontainers. Optionally, the device 1100 may be left in contact with thetarget fluid and the containers engaged into fluid contact with thechannels so that the fill will draw fluid in the channel and perhapsalso any additional sample fluid that remains at the target site. Thismay ensure that enough bodily fluid is drawn into the containers.

After filling the containers 1146 a and 1146 b, they may be prepared forshipment. Optionally, they may be sent for pre-treatment before beingshipped. Some embodiments of the containers 1146 a and 1146 b include amaterial in the container of a density such that after a pre-treatmentsuch as centrifugation, the material due to its selected density willseparate one portion of the centrifuged sample from another portion ofthe centrifuged sample in the same container.

The container 1146 a or 1146 b may have a vacuum and/or negativepressure therein. The sample may be drawn into the container when thechannel is brought into fluidic communication with the vacu-container.Optionally, the container may take the form of a test tube-like devicein the nature of those marketed under the trademark “Vacutainer” byBecton-Dickinson Company of East Rutherford, N.J. The device may remainin a compressed state with the base 1140 closing gap 1160 while thesample is being transferred to the container. The sample may fill theentire container or a portion of the container. The entirety of thesample (and/or greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% ofthe sample) from the channels may be transferred to the containers.Alternatively, only a portion of the sample from the channels may betransferred to the containers.

In one embodiment as described herein, a two-stage filling of the samplefluid into the sample collection device 1100 allows for i) meteredcollection of the sample fluid to ensure that a sufficient amount isobtained in a collection channel that is treated to prevent prematureclotting and then ii) an efficient manner of transferring a highpercentage of the sample fluid into the container. This low loss fillingof container from pre-fill channels to meter a minimum amount of samplefluid into the container 1146 provides for multiple advantages,particularly when dealing with collecting small volumes of sample fluid.Pre-filling the channels to a desired level ensures sufficient volume ispresent in the container to perform the desired testing on the samplefluid.

In another embodiment as described herein, the entire device includingthe sample fill portion 1120, support 1130, and base 1140 are entirelytransparent or translucent to allow for visualization of the componentstherein. Optionally, only one of the body 1120, support 1130, and base1140 are fully transparent or translucent. Optionally, only selectportions of sample fill portion 1120, support 1130, or base 1140 aretransparent or translucent. The user may then more accurately determinewhen to perform various procedures based on progression of sample fluidfilling and engagement of the sample containers to the channels insample fill portion 1120. Air bubbles in the collection channel may bevisible during filling and if they are seen, a user may adjust theposition of the sample collection device 1100 to better engage thetarget sample fluid to minimize air being drawn into the channels. Itwill also allow the user to know when to breakaway or disengage piecessuch as the base or container holder 1140 when filling is completed.

It should be understood that other methods can be used to preventoutward sample flow from the adapter channels 1150 and 1152 if thedevice is held at a non-horizontal angle such as but not limited todownwardly in a vertical manner. In one embodiment, a frit 1194 can beused with needles with a central bore that are used as the adapterchannels 1150 and 1152. The frits can be in the body of samplecollection device or on the collection vessels. In some embodiments, thefrits comprise of a material such as but not limited to PTFE.Optionally, some embodiments may use tape/adhesive over the needles thatare functioning as the adapter channels 1150 and 1152. In oneembodiment, the tape and/or adhesive may be used to cover the needleopenings to prevent premature discharge of sample. Optionally, someembodiments may have adapter channels 1150 and 1152 having hydrophobicsurface to prevent controlled outflow from the adapter channel openingsleading toward the sample containers. In some embodiments, the adapterchannels 1150 and 1152 are needles with hydrophobic material only on theinterior surfaces near an exit. Optionally, the hydrophobic material isonly on the exterior needle surfaces near an exit. Optionally, thehydrophobic material is on interior and exterior needle surfaces.Optionally, another method of preventing downward flow is increasing thesurface area of the capillaries by varying the cross-section. By way ofnon-limiting example, some embodiments may introduce teeth- orfinger-like structures within the capillary in order increase surfaceare in the cross-section of the capillary. Optionally, some embodimentsmay include fins oriented toward and/or against the fluid flow withinthe capillary in order increase surface are in the cross-section of thecapillary. There may be variations and alternatives to the embodimentsdescribed herein and that no single embodiment should be construed toencompass the entire invention.

One Sample Collector Location to Multiple Channels

Referring now to FIGS. 13A-13B, yet another embodiment as describedherein will now be described. FIG. 13A shows a top down view of a samplefill portion 1320 with a single collection location 1322 such as but notlimited to a collection well where two channels 1324 and 1326 meet todraw fluid away from the single collection location 1322. Optionally,some embodiments may use an Y-split channel configuration wherein only asingle channel lead away from the collection location 1322 and thensplits into channels 1324 and 1326 after having been a single commonchannel leading away from the collection location 1322. Membersproviding fluid communication to the channels 1324 and 1326, such as butnot limited to a needle, probe, tube, channel, hollow elongate member,or other structure, may be coupled to one end of the sample fill portion1320.

FIG. 13B shows a side-cross-sectional view, wherein the collectionlocation 1322 is shown and in fluidic communication with channel 1326which is in turn in fluid communication with an adapter channel 1352such as but not limited to a fluid communication member. Someembodiments, the fluid communication member may have sufficientstiffness and a sufficiently penetrating tip to pierce a septum, cap, orother structure of the container. Some may have the adapter channel1352, 1150, or the like to be a non-coring structure so as not to leavebehind a hole that will not seal in the septum, cap, or other structureof the container.

As seen in FIG. 13B, sample fluid may be applied or dropped into thecollection location 1322 as indicated by droplet D. Optionally, some maydirectly apply or directly contact the collection location 1322 to applythe sample fluid. Although the embodiments herein are shown to use onlya single collection location 1322, it should be understood that otherembodiments where multiple channels couple to a common sample collectionpoint are envisioned. By way of nonlimiting example, one embodiment of acollection device may have two collection locations 1322, each with itsown set of channels leading away from its respective collectionlocation. Some embodiments may combine common collection point channelsshown in FIGS. 13A-B with channels that are separate such as shown inFIGS. 11A-11F. Other combinations of common collection locationstructure with other structures with separate channels are not excluded.

FIG. 13B also shows that this embodiment may include one or more tissuepenetrating members 1327 configured to extend outward from thecollection location 1322. In one embodiment, this enables the user toplace target tissue simultaneously over the collection location 1322 andthe wound creation location for fluid sample acquisition. Optionally, atrigger 1323 can be positioned to launch the tissue penetrating member.Optionally, the trigger is built into a tissue interface of the deviceto enable launch of the device when the target tissue is contactedand/or when sufficient pressure or contact is in place. This overlap ofthese two locations allows for simplified protocol for users to followfor successful sample acquisition. The tissue penetration member(s) 1327may be actuated by one or more actuation techniques such as but notlimited to spring actuated, spring/cam actuated, electronicallyactuated, or single or multiple combinations of the foregoing. It shouldbe understood that other assist methods such as but not limited tovacuum sources, tissue stretching devices, tissue engagement nosepieces, or the like may be used alone or in combination with any of theforegoing for improved sample acquisition.

Referring now to FIG. 13C, a still further embodiment of a samplecollection device will now be described. This embodiment shows acartridge 1400 with a sample collection device 1402 integrated therein.There is a collection location 1322 and one or more sample openings 1325and 1329 where sample collection at location 1322 can then be accessedsuch as but not limited to handling by a pipette tip (not shown). Thesample from droplet D will travel along pathway 1326 as indicated byarrow towards the openings 1325 and 1329, where the sample in theopening and any in the pathways 1324 and/or 1326 leading towards theirrespective openings 1325 and 1329 are drawn into the pipette P. Asindicated by arrows near the pipette P, the pipette P is movable in atleast one axis to enable transport of sample fluid to the desiredlocation(s). In this embodiment, the cartridge 1400 can have a pluralityof holding containers 1410 for reagents, wash fluids, mixing area,incubation areas, or the like. Optionally, some embodiments of thecartridge 1400 may not include any holding containers or optionally,only one or two types of holding containers. Optionally, in someembodiments, the holding containers may be pipette tips. Optionally, insome embodiments, the holding containers are pipette tips that aretreated to contain reagent(s) on the tip surface (typically the interiortip surface although other surfaces are not excluded). Optionally, someembodiments of the cartridge 1400 may include only the sample collectiondevice 1402 without the tissue penetrating member or vice versa.

Referring now to FIG. 13D, a side cross-sectional view of the embodimentof FIG. 13C is shown. Optionally, a tissue penetrating member 1327 maybe included for use with creating the wound for the sample fluid to becollected at location 1322.

FIG. 14 shows that the sample fill portion 1320 may be joined withsupport 1330 and 1340 to form the sample collection device 1300. Theremay be a visualization window 1312 to see if sample fluid has reached adesired fill level. A force-exerting component, such as a spring 1356 orelastic may be included. The channel holder may keep the channel affixedto the support. In one embodiment, the holder may prevent the channelfrom sliding relative to the support. It may use a press fit, mechanicalfastening, adhesive, or other attachment technique to couple to thechannel. The holder may optionally provide a support upon which aforce-exerting component, such as a spring, may rest.

In one example, the engagement assemblies may include a spring 1356which may exert a force so that the base 1340 is at an extended state,when the spring is at its natural state. When the base is at itsextended state, space may be provided between the containers 1346 a,1346 b and the engagement assemblies. In some instances, when the base1340 is in its extended state, the second ends of the channels may ormay not contact the caps of the containers. The second ends of the fluidcommunication members 1352 may be in a position where they are not influid communication with the interiors of the containers.

Bringing the support 1330 and the base 1340 together will bring thechannels 1324 and 1326 into fluid communication with the containers 1346a and 1346 b when the members 1352 penetrate through the cap on thecontainers and thus draw sample fluid into the containers 1346 a and1346 b.

The container 1346 a or 1346 b may have a vacuum and/or negativepressure therein. The sample may be drawn into the container when thechannel is brought into fluidic communication with the vacu-container.The device may remain in a compressed state with the base 1340positioned so that containers are in fluid communication with thechannels 1326 and 1328 when the sample fluid is being transferred to thecontainers. The sample may fill the entire container or a portion of thecontainer. The entirety of the sample (and/or greater than 90%, 95%,97%, 98%, 99%, 99.5% or 99.9% of the sample) from the channels may betransferred to the containers. Alternatively, only a portion of thesample from the channels may be transferred to the containers.

As seen in FIG. 15, in one embodiment as described herein, a two-stagefilling of the sample fluid into the sample collection device 1300allows for i) metered collection of the sample fluid to ensure that asufficient amount is obtained in a collection channel that is treated toprevent premature clotting and then ii) an efficient manner oftransferring a high percentage of the sample fluid into the container.This low loss filling of container from pre-fill channels to meter aminimum amount of sample fluid into the container 1346 provides formultiple advantages, particularly when dealing with collecting smallvolumes of sample fluid. Pre-filling the channels to a desired levelensures sufficient volume is present in the container to perform thedesired testing on the sample fluid.

Referring now to FIGS. 16 and 17, still further embodiments will now bedescribed. FIG. 16 shows a blood collection device 1300 with a secondarycollection area 1324 around the collection location 1322. The secondarycollection area 1324 can be used to direct any overflow, spilled, ormis-directed fluid sample towards the collection location 1322.

FIG. 17 further shows that the containers 1346 a and 1346 b may eachhave an identifier associated with the containers 1346 a and 1346 b.FIG. 17 shows that in one nonlimiting example, the identifier 1600 and1602 may be at least one of: a barcode (e.g., 1-D, 2-D, or 3-D), quickresponse (QR) code, image, shape, word, number, alphanumeric string,color, or any combination thereof, or any type of visual identifier.Others may use identifiers that are not in the visible spectrum. Othersmay use RFID tags, RF identifiers, IR emitting tags, or other markersthat do not rely on identification through signals sent through thevisual spectrum.

Identifiers 1600 and 1602 may be used to identify sample and/or types ofsample in a sample collection device. There may be one or moreidentifiers per container. Some may also use identifiers on thecontainer holders. Identifiers may identity the sample collectiondevice, one or more individual containers within the device, orcomponents of the device. In some instances, the sample collectiondevice, a portion of the sample collection device, and/or the containersmay be transported. In one example, the sample collection device,portion of the sample collection device may be transported via adelivery service, or any other service described elsewhere herein. Thesample may be delivered to perform one or more test on the sample.

The sample identity and/or the identity of the individual who providedthe sample could be tracked. Information associated with the individualor individuals (e.g., name, contact information, social security number,birth date, insurance information, billing information, medical history)and other information of who provided the sample may be included. Insome instances, the type of sample (e.g., whole blood, plasma, urine,etc.) may be tracked. The types of reagents that the sample will haveencountered (e.g., anticoagulants, labels, etc.) could also be tracked.Additional information about the sample collection, such as date and/ortime of collection, circumstances under which sample was collected,types of tests to be run on the sample, insurance information, medicalrecords information, or any other type of information may be considered.

Identifiers may assist with tracking such information. The identifiersmay be associated with such information. Such information may be storedoff-board the sample collection device, on-board the sample collectiondevice, or any combination thereof. In some instances, the informationmay be stored on one or more external devices, such as servers,computers, databases, or any other device having a memory. In someinstances, the information may be stored on a cloud computinginfrastructure. One or more resources that store the information may bedistributed over the cloud. In some instances, a peer-to-peerinfrastructure may be provided. The information may be stored in theidentifier itself, or may be associated with the identifier elsewhere,or any combination thereof.

An identifier may provide unique identification, or may provide a highlikelihood of providing unique identification. In some instances, theidentifier may have a visible component. The identifier may be opticallydetectable. In some instances, the identifier may be discernible usingvisible light. In some examples, the identifier may be a barcode (e.g.,1-D, 2-D, or 3-D), quick response (QR) code, image, shape, word, number,alphanumeric string, color, or any combination thereof, or any type ofvisual identifier.

In other embodiments, the identifier may be optically detectable via anyother sort of radiation. For example, the identifier may be detectablevia infrared, ultraviolet, or any other type of wavelength of theelectromagnetic spectrum. The identifier may utilize luminescence, suchas fluorescence, chemiluminescence, bioluminescence, or any other typeof optical emission. In some instances, the identifier may be a radiotransmitter and/or receiver. The identifier may be a radiofrequencyidentification (RFID) tag. The identifier may be any type of wirelesstransmitter and/or receiver. The identifier may send one or moreelectrical signal. In some instances, GPS or other location-relatedsignals may be utilized with the identifier.

An identifier may include an audio component, or acoustic component. Theidentifier may emit a sound that may be discernible to uniquely identifythe identified component.

The identifier may be detectable via an optical detection device. Forexample, a bar code scanner may be capable of reading the identifier. Inanother example, a camera (e.g., for still or video images) or otherimage capture device may be capable of capturing an image of theidentifier and analyzing the image to determine the identification.

FIGS. 16 and 17 show examples of identifiers provided for use with asample collection device 1300 in accordance with an embodiment describedherein. In one example, a sample collection device may include a base1340 which may support and/or contain one or more containers 1346 a,1346 b. Sample may be provided to the sample collection device. Thesample may be provided to the sample collection device via an inlet1322. The sample may travel to one or more containers 1346 a, 1346 bwithin the device.

One or more identifier 1600, 1602 may be provided on the samplecollection device. In some embodiments, identifiers may be positioned ona base 1340 of the sample collection device. The identifiers may bepositioned on a bottom surface of the base, side surface of the base, orany other portion of the base. In one example, the base may have a flatbottom surface. The identifiers may be on the flat bottom surface of thebase. One or more indentation may be provided in the base. Theidentifier may be located within the indentation. The indentations maybe on the bottom or side surface of the base. In some embodiments, thebase may include one or more protrusion. The identifier may be locatedon the protrusion. In some instances, the identifiers may be provided onan exterior surface of the base. The identifiers may alternatively bepositioned on an interior surface of the base. The identifiers may bedetected from outside the sample collection device.

In some embodiments, the identifiers may be provided on the containers1346 a, 1346 b. The identifiers may be on an exterior surface of thecontainers or an interior surface of the containers. The identifiers maybe detectable from outside the containers. In some embodiments, theidentifiers may be provided on a bottom surface of the containers.

In one example, the base may include an optically transmissive portion.The optically transmissive portion may be on a bottom of the base or aside of the base. For example, a transparent or translucent window maybe provided. In another example, the optically transmissive portion maybe a hole without requiring a window. The optically transmissive portionmay permit a portion inside the base to be visible. The identifiers maybe provided on an exterior surface of the base on the opticallytransmissive portion, an interior surface of the base but may be visiblethrough the optically transmissive portion, or on an exterior orinterior surface of the container but may be visible through theoptically transmissive portion. In some instances, the identifier may beprovided on an interior surface of the container, but the container maybe optically transmissive so that the identifier is viewable through thecontainer and/or optically transmissive portion.

The identifier may be a QR code or other optical identifier that may beoptically visible from outside the sample collection device. A QR codemay be visible through an optical window or hole at the bottom of thebase of the sample collection device. The QR code may be provided on thesample collection device base or on a portion of the container visiblethrough the base. An image capturing device, such as a camera or scannermay be provided externally to the sample collection device, and may becapable of reading the QR code.

A single or a plurality of QR codes or other identifiers may be providedon a sample collection device. In some instances, each container mayhave at least one identifier, such as a QR code associated with it. Inone example, at least one window may be provided in a base percontainer, and each window may permit a user to view a QR code or otheridentifier. For example, two containers 1346 a, 1346 b may be housedwithin a base 1340, each of which has an associated identifier 1600,1602 discernible from outside the sample collection device.

The base 1340 may be separable from the support 1330 or other portionsof the sample collection device. The identifier(s) may be separated fromthe rest of the sample collection device along with the base.

In some embodiments, the identifiers may be provided with containershoused by the base. Separating the base from the rest of the samplecollection device may cause the containers to be separated from the restof the sample collection device. The containers may remain within thebase or may be removed from the base. The identifiers may remain withthe containers even if they are removed from the base. Alternatively,the identifiers may remain with the base even if containers are removed.In some instances, both the base and containers may have identifiers sothat the containers and bases may be individually tracked and/or matchedeven when separated.

In some instances, any number of containers may be provided within thesample collection device. The sample containers may be capable ofreceiving sample received from a subject. Each sample container may havea unique identifier. The unique identifier may be associated with anyinformation relating to the sample, subject, device, or component of thedevice.

In some instances, each identifier for each container may be unique. Inother embodiments, the identifier on the container need not be unique,but may be unique for the device, for the subject, or for the type ofsample.

A sample collection device may receive a sample from a subject. Thesubject may directly contact the sample collection device or provide thesample to the device. The sample may travel through the device to one ormore containers within the device. In some instances, the sample may betreated prior to reaching the containers. One or more coating orsubstance may be provided within a sample collection unit and/or channelthat may convey the sample to the containers. Alternatively, notreatment is provided to the sample prior to reaching the container. Insome embodiments, the sample may or may not be treated within thecontainer. In some instances, a plurality of different types oftreatments may be provided to a sample before or when the sample reachesthe container. The treatments may be provided in a preselected order.For example, a first treatment desired first, and may be providedupstream of a second treatment. In some instances, the sample is nottreated at any point.

In some embodiments, the sample may be a blood sample. A first containermay receive whole blood and a second container may receive blood plasma.Anticoagulants may be provided along the fluid path and/or in thecontainers.

Once the sample has been provided to the containers and the containershave been sealed, the containers may be sent to a separate location forsample analysis. The separate location may be a laboratory. The separatelocation may be a remote facility relative to the sample collectionsite. The entire sample collection device may be sent to the separatelocation. One or more identifiers may be provided on the samplecollection device and may be useful for identifying the samplecollection device and/or containers therein. Alternatively, the base1340 may be removed from the sample collection device and may be sent tothe separate location with the containers therein. One or moreidentifiers may be provided on the base and may be useful foridentifying the base and/or containers therein. In some instances,containers may be removed from the base and may be sent to the separatelocation. One or more identifier may be provided on each container, andmay be useful for identifying the containers.

The identifiers may be read by any suitable technique. By way of exampleand not limitation, in some instances, the identifiers are read using anoptical detector, such as an image capture device or barcode scanner. Inone example, an image capture device may capture an image of a QR code.Information relating to the container may be tracked. For example, whena container arrives at a location, the identifier may be scanned, andrecord of the arrival of the container may be kept. The progress and/orlocation of the container may be updated actively and/or passively. Insome instances, the identifier may need to be scanned intentionally inorder to determine the location of the container. In other examples, theidentifier may actively emit a signal that may be picked up by signalreaders. For example, as an identifier travels through a building,signal readers may track the location of the identifier.

In some instances, reading the identifier may permit a user to accessadditional information associated with the identifier. For example, theuser may capture an image of the identifier using a device. The deviceor another device may display information about the sample, subject,device, component of the device, or any other information describedelsewhere herein. Information about tests to be conducted and/or testresults may be included. The user may perform subsequent tests oractions with the sample based on information associated with theidentifier. For example, the user may direct the container to theappropriate location for a test. In some instances, the container may bedirected to an appropriate location and/or have appropriate sampleprocessing (e.g., sample prep, assay, detection, analysis) performed onthe contents of the container in an automated fashion without requiringhuman intervention.

Information relating to sample processing may be collected andassociated with the identifier. For example, if a container has anidentifier and sample processing has been performed on the contents ofthe container, one or more signals produced in response to the sampleprocessing may be stored and/or associated with the identifier. Suchupdates may be made in an automated fashion without requiring humanintervention. Alternatively, a user may initiate the storing ofinformation or may manually enter information. Thus, medical recordsrelating to a subject may be aggregated in an automated fashion. Theidentifiers may be useful for indexing and/or accessing informationrelated to the subject.

Fluid Containers

FIGS. 18A-18B show one nonlimiting example of a container 1800 that maybe utilized with a sample collection device in accordance with anembodiment described herein. In some instances, the containers may besupported by the sample collection device. The containers may beencompassed or surrounded by a portion of the sample collection device.In one example, the sample collection device may have a firstconfiguration where the containers are completely enclosed. A secondconfiguration may be provided where the sample collection device may beopened and at least a portion of the containers may be exposed. In someexamples, the containers may be supported and/or at least partiallyenclosed by a base of the sample collection device. The base may beseparable from the rest of the sample collection device, therebyproviding access to the containers therein.

In one embodiment, a container 1800 comprises a body 1810 and a cap1820. In some instances, the container body may be formed from atransparent or translucent material. The container body may permit asample provided within the container body to be visible when viewed fromoutside the container. The container body may be optically transmissive.The container body may be formed of a material that may permitelectromagnetic radiation to pass through. In some instances, thecontainer body may be formed of a material that may permit selectedwavelengths of electromagnetic radiation to pass through while notpermitting other non-selected wavelengths of electromagnetic radiationto pass through. In some instances a portion or all of the body may beformed of a material that is opaque along selected wavelengths ofelectromagnetic radiation, such as wavelengths for visible light.

An open end and a closed end may be provided on a container body 1810.The open end may be a top end 1812 of the container 1800, which may beat the end which may be configured to engage with a cap. The closed endmay be a bottom end 1814 of the container, which may be at the end ofthe container opposite the cap. In alternative embodiments, a bottom endmay also be an open end that may be closable with a floor. In someembodiments, the cross-sectional area and/or shape of the top end andthe bottom end may be substantially the same. Alternatively, thecross-sectional area of the top end may be larger than thecross-sectional area of the bottom end, or vice versa. There may bevariations and alternatives to the embodiments described herein and thatno single embodiment should be construed to encompass the entireinvention.

A container body may have an interior surface and an exterior surface.The surfaces of the container body may be smooth, rough, textured,faceted, shiny, dull, contain grooves, contain ridges, or have any otherfeature. The surface of the container body may be treated to provide adesired optical property. The interior surfaces and exterior surfacesmay have the same properties or may be different. For example, anexterior surface may be smooth while the interior surface is rough.

The container body may have a tubular shape. In some instances, thecontainer body may have a cylindrical portion. In some instances, thecontainer may have a circular cross-sectional shape. Alternatively, thecontainer may have any other cross-sectional shape which may includeelliptical, triangular, quadrilateral (e.g., square, rectangular,trapezoidal, parallelogram), pentagonal, hexagonal, heptagonal,octagonal, or any other shape. The cross-sectional shape of thecontainer may or may not have a convex and/or concave shape. Thecross-sectional shape of the container may remain the same along thelength of the container, or may vary. The container may have a prismaticshape along the length of the body. The prism may have a cross-sectionalshape as those described herein.

The bottom 1814 of the container may be flat, tapered, rounded, or anycombination thereof. In some instances, the container may have ahemispherical bottom. In other embodiments, the container may have arounded bottom with a flat portion. The container may or may not becapable of standing on a flat surface on its own.

The containers 1800 may be sized to contain a small fluid sample. Insome embodiments, the containers may be configured to contain no morethan about 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 uL, 800 uL, 700 uL,600 uL, 500 uL, 400 uL, 300 uL, 250 uL, 200 uL, 150 uL, 100 uL, 80 uL,50 uL, 30 uL, 25 uL, 20 uL, 10 uL, 7 uL, 5 uL, 3 uL, 2 uL, 1 uL, 750 mL,500 mL, 250 mL, 200 mL, 150 mL, 100 mL, 50 mL, 10 mL, 5 mL, 1 mL, 500pL, 300 pL, 100 pL, 50 pL, 10 pL, 5 pL, or 1 pL. The containers may havethe identifiers thereon such as discussed for FIGS. 16 and 17. In onenon-limiting example, the containers 1800 may hold the small volume ofsample fluid in liquid form without the use of a wicking material or thelike to hold the sample fluid during transport. This allows the samplefluid to be substantially removed in liquid form from the containerwithout loss due to liquid being absorbed by the wicking material.

The containers 1800 may be configured to contain no more than severaldrops of blood, a drop of blood, or no more than a portion of a drop ofblood. For example, the container may have an interior volume of nogreater than the amount of fluid sample it is configured to contain.Having a small volume container may advantageously permit storage and/ortransport of a large number of containers within a small volume. Thismay reduce resources used to store and/or transport the containers. Forexample, less storage space may be required. Additionally, less costand/or fuel may be used to transport the containers. For the same amountof exertion, a larger number of containers may be transported.

In some embodiments, the container 1800 may have a small length. Forexample, the container length may be no greater than 8 cm, 7 cm, 6 cm, 5cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1.5 cm, 1.3 cm, 1.1 cm, 1cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm, 0.1cm, 700 um, 500 m, 300 um, 100 um, 70 um, 50 um, 30 um, 10 um, 7 um, 5um, 30 um, or 1 um. In some instances, the greatest dimension of thecontainer (e.g., length, width, or diameter) may be no greater than 8cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1.5 cm,1.3 cm, 1.1 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm,0.3 cm, 0.2 cm, 0.1 cm, 700 um, 500 m, 300 um, 100 um, 70 um, 50 um, 30um, 10 um, 7 um, 5 um, 30 um, or 1 um.

The container 1800 may have any cross-sectional area. Thecross-sectional area may be no greater than about 8 cm², 7 cm², 6 cm², 5cm², 4 cm², 3.5 cm², 3 cm², 2.5 cm², 2 cm², 1.5 cm², 1 cm², 0.9 cm², 0.8cm², 0.7 cm², 0.6 cm², 0.5 cm², 0.4 cm², 0.3 cm², 0.2 cm², 0.1 cm², 0.07cm², 0.05 cm², 0.03 cm², 0.02 cm², 0.01 cm², 0.5 cm², 0.3 cm², or 0.1cm². The cross-sectional area may remain the same or may vary along thelength of the container.

The container 1800 may have any thickness. The thickness may remain thesame along the length of the container or may vary. In some instances,the thickness may be selected and/or may vary in order to provide adesired optical property. In some instances, the thickness may be nogreater than 5 mm, 3 mm, 2 mm, 1 mm, 700 um, 500 um, 300 um, 200 um, 150um, 100 um, 70 um, 50 um, 30 um, 10 um, 7 um, 5 um, 3 um, 1 um, 700 nm,500 nm, 300 nm or 100 nm.

The container 1800 may have a shape conducive to enabling centrifugationof small volume blood samples. This allows the collected sample in thecontainers to be taken directed to a centrifuge without having tofurther transfer the sample fluid to yet another container that is usedin the centrifuge device.

The containers may contain a cap 1820. The cap may be configured to fitover an open end of the container. The cap may block the open end of thecontainer. The cap may fluidically seal the container. The cap may forma fluid-tight seal with the container body. For example, the cap may begas and/or liquid impermeable. Alternatively, the cap may permit certaingases and/or liquids to pass through. In some instances, the cap may begas permeable while being liquid impermeable. The cap may be impermeableto the sample. For example, the cap may be impermeable to whole blood,serum or plasma.

The cap may be configured to engage with the container body in anymanner. For example, the cap may be press-fit with the container body. Afriction fit may permit the cap to stay on the body. In other examples,a locking mechanism may be provided, such as a sliding mechanism, clamp,fastener, or other technique. In some instances, the cap and/or thecontainer body may be threaded to permit a screw-type engagement. Inother examples, adhesives, welding, soldering, or brazing may beutilized to connect the cap to the container body. The cap may beremovably attached to the container body. Alternatively, the cap may bepermanently affixed to the container body.

In some instances, a portion of the cap may fit into a portion of thecontainer body. The cap may form a stopper with the container body. Insome instances, a portion of the container body may fit into a portionof the cap. The plug may include a lip or shelf that may hang over aportion of the container body. The lip or shelf may prevent the cap fromsliding into the container body. In some instances, a portion of a capmay overlie a top and/or side of the container body. Optionally, someembodiments may include an additional part in the vessel assembly suchas cap holder. In one embodiment, the purpose of the cap holder is tomaintain a tight seal between the cap and container. In one embodiment,the cap holder engages an attachment, lip, indentation, or otherattachment location on the outside of the container to hold the cap inposition. Optionally, some embodiments can combine the function of boththe cap and the cap holder into one component.

In some embodiments, the container body may be formed of a rigidmaterial. For example, the container body may be formed of a polymer,such as polypropylene, polystyrene, or acrylic. In alternateembodiments, the container body may be semi-rigid or flexible. Thecontainer body may be formed from a single integral piece.Alternatively, multiple pieces may be used. The multiple pieces may beformed from the same material or from different materials.

The container cap may be formed of an elastomeric material, or any othermaterial described elsewhere herein. In some instances, the cap may beformed from a rubber, polymer, or any other material that may beflexible and/or compressible. Alternatively, the cap may be semi-rigidor rigid. The container cap may be formed from a high friction material.The container cap may be capable of being friction-fit to engage withthe container body. When the container cap is engaged with the containerbody, a fluid-tight seal may be formed. The interior of the containerbody may be fluidically isolated from the ambient air. In someinstances, at least one of the cap and/or portion of the container bodycontacting the cap may be formed from a high friction and/orcompressible material.

The container cap may be formed from a single integral piece.Alternatively, multiple pieces may be used. The multiple pieces may beformed from the same material or from different materials. The capmaterial may be the same as or different from the container bodymaterial. In one example, the container body may be formed from anoptically transmissive material while the cap is formed from an opaquematerial.

The cap 1820 may be removably engaged with the body. A portion of thecap may be insertable into the body. The cap may include a lip which mayrest on top of the body. The lip is not inserted into the body. In thisnon-limiting example, the lip may prevent the cap from being entirelyinserted into the body. The lip may form a continuous flange around thecap. In some instances, a portion of the lip may overlap or overlie aportion of the body. A portion of the body may be insertable into aportion of the cap.

The portion of the cap that may be insertable into the body may have arounded bottom. Alternatively, the portion may be flat, tapered, curved,contoured, or have any other shape. The cap may be shaped to be easilyinsertable into the body.

In some instances, a depression may be provided at the top of the cap.The depression may follow the portion of the cap that is inserted intothe body. In some instances, a hollow or depression may be provided inthe cap. The depression may be capable of accepting a portion of achannel that may be used to deliver a sample to the container. Thedepression may assist with guiding the channel to a desired portion ofthe cap. In one example, the channel may be positioned within thedepression prior to bringing the channel and interior of the containerinto fluid communication.

The channel and cap may be pressed together so that the channelpenetrates the cap and enters the interior of the container, therebybringing the channel and interior of the container into fluidcommunication. In some instances, the cap may have a slit through whichthe channel passes. Alternatively, the channel may poke throughuninterrupted cap material. The channel may be withdrawn from thecontainer, thereby bringing the channel and container out of fluidcommunication. The cap may be capable of resealing when the channel isremoved. For the example, the cap may be formed of a self-healingmaterial. In some instances, the cap may have a slit that may close upwhen the channel is removed, thereby forming a fluid tight seal.

In some embodiments, the body may include one or more flange or othersurface feature. Examples of surface features may include flanges,bumps, protrusions, grooves, ridges, threads, holes, facets, or anyother surface feature. The flange and/or other surface feature maycircumscribe the body. The flange and/or surface feature may be locatedat or near the top of the body. The flange and/or other surface featuremay be located at the top half, top third, top quarter, top fifth, topsixth, top eighth, or top tenth of the body. The surface features may beuseful for support of the container within a sample collection device.The surface features may be useful for removing the container from thesample collection device and/or positioning the container within thesample collection device. The flange and/or other surface feature may ormay not engage with the cap.

The cap may have any dimension relative to the container body. In someinstances, the cap and/or body may have similar cross-sectional areas.The cap may have the same, or a substantially similar cross-sectionalarea and/or shape as the top of the body. In some instances, the cap mayhave a lesser length than the body. For example, the cap may have alength that may be less than 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%,5%, 3% or 1% of the length of the body.

Referring now to FIGS. 18C to 18E, a still further embodiment ofcontainer 1800 may include a cap holder 1830 that fits over the cap tohold the cap in place. By way of non-limiting example, the cap holder1830 may also include an opening in the cap holder 1830 that allows fora member such as an adapter to slide through and penetrate the cap 1820.FIG. 18C shows the parts in an exploded view.

FIG. 18D shows a cross-section view showing one embodiment wherein thecontainer body 1810 having a cap 1820 covered by a cap holder 1830. Asseen in FIG. 18D, the cap holder 1830 has a locking feature 1832 forsecuring the cap holder 1830 to the container body 1810 and/or the cap1820. In one embodiment, the locking feature 1832 comprises an interiorridge which will engage one or more of the ridges 1812 and 1814 on thecontainer body 1810. FIG. 18E shows a side view of the cap holder 1830coupled to the container body 1810.

In some instances, a surface of the container may be coated and/ortreated with a material. For example, an interior surface of thecontainer may be coated with fixatives, antibodies, optical coatings,anticoagulant, and/or preservatives. These may be the same or differentfrom any material coatings in the channels.

The coating may be a wet or dry coating. Some embodiments may have atleast one dry coating and at least one wet coating. In some instancesone or more reagents may be coated and dried on the interior surface ofthe container. The coating may alternatively be provided in a moistenvironment or may be a gel. One or more solid substrate may be providedwithin the container. For example one or more bead or particle may beprovided within the container. The beads and/or particles may be coatedwith reagents or any other substance described herein. The beads and/orparticles may be capable of dissolving in the presence of the sample.The beads and/or particles may be formed from one or more reagents ormay be useful for treating the sample. A reagent may be provided in agaseous form within the container. The container may be sealed. Thecontainer may remain sealed before the sample is introduced into thecontainer, after the sample has been introduced to the container, and/orwhile the sample is being introduced into the container. In oneembodiment, the containers may have smooth surfaces and/or roundbottoms. This is helpful to minimize the stress on the blood sample,especially during centrifugation. Of course, in alternative embodiments,other shapes of the bottom of the container are not excluded.

Referring now to FIGS. 19A to 19C, various embodiments of a front end ofa sample collection device will now be described. FIG. 19A shows on viewof a front end of the sample collection device with openings 1103 and1105 for their respective channels. In the present embodiment, theopenings 1103 and 1105 are placed in close proximity to each other withthe divider wall 1910 between the openings 1103 and 1105. In onenon-limiting example, the thickness of divider wall 1910 is set to bethe minimum thickness that can be reliably formed through amanufacturing process used to form the sample collection device. In oneembodiment, wall thickness should be about 1-10 mm. In some embodiments,instead of being side by side, the openings 1103 and 1105 may be in atop-bottom configuration, diagonal configuration, or other configurationwhere the two openings are in close proximity to one another.

Referring now to FIG. 19B, this embodiment shows the openings 1910 and1912 configured to be coaxial, relative to one another. This coaxialconfiguration of openings 1910 and 1912 allows for greater overlapbetween the two openings.

Referring now to FIG. 19C, this embodiment is similar to that of FIG.19B except that instead of square shaped openings, these openings 1920and 1922 are round. It should be understood that any variety of shapesmay be used including but not limited to circular, elliptical,triangular, quadrilateral (e.g., square, rectangular, trapezoidal),pentagonal, hexagonal, octagonal, or any other cross-sectional shape. Ofcourse, it should be understood that different shapes can be used foreach opening and that a collection device need not have the samecross-sectional shape for all openings. Some embodiments may have a onecross-sectional shape for the opening but have a differentcross-sectional shape for channel downstream from the opening.

Single Channel Sample Collection Device

Referring now to FIGS. 20A-20B, although the embodiments herein aretypically described as sample collection devices with two separatechannels, it should be understood that some embodiments may use a singleentry channel 2010. This single entry channel 2010 may or may not becoated. Suitable coatings include but not are limited to ananti-coagulant, plasma, or other materials.

FIG. 20A shows that in this embodiment of sample collection device 2000,a tissue penetrating member 2112 can be mounted coaxially within thesingle entry pathway 2010. This allows the wound at the target tissue tobe formed in a manner that will be aligned with the single entry pathway2010. The tissue penetrating member 2012 can be activated by one of avariety of techniques such as but not limited to actuation upon pressinga trigger, actuation upon contact of the device front end with thetarget tissue, or by pressure once the device is pressed against thetarget tissue with sufficient pressure. After actuation, the tissuepenetrating member 2012 can remain in the single entry pathway 2010.Optionally, the tissue penetrating member 2012 may retract out of thesingle entry pathway 2010.

The sample fluid entering the sample collection device 2000 may splitinto two or more separate pathways 2014 and 2016 from the single entrypathway 2010. This enables the sample fluid to be split into at leasttwo portions from a sample collected from a single point of contact. Thetwo portions may optionally be held in two separate holding chambers2018 and 2020. These chambers may each have one or more adapter channels2022 and 2024 to transfer the sample fluid to the containers such as butnot limited to containers 1146 a and 1146 b. It should be understoodthat the holding chambers 2018 and 2020 and/or the containers 1146 a and1146 b may contain anti-coagulant therein to prepare the sample fluidfor processing.

Referring now to FIG. 20B, this embodiment shows that the single entrypathway 2010 with a tissue penetrating member 2012 therein that, afteractuation, is configured to remain in whole or in part within the singleentry pathway 2010. It should be understood that this embodiment may usea solid penetrating member or one that is hollow, with a lumen therein.

Referring now to FIG. 21, yet another embodiment of a sample collectiondevice 2030 will now be described. This embodiment shows a reducedlength single entry pathway 2032 with a tissue penetrating member 2012configured to extend outward from the pathway 2032. After actuation, thetissue penetrating member 2012 may be in the pathway 2032 or optionally,retracted to not be in the pathway 2032. The sample fluid entering thesample collection device 2030 may split into two or more separatepathways 2034 and 2036 from the single entry pathway 2032. This enablesthe sample fluid to be split into at least two portions from a samplecollected from a single point of contact. This embodiment shows that thepathways 2034 and 2036 remain in capillary channel configuration and donot enlarge to become chambers such as the embodiments of FIGS. 20A-20B.It should be understood that any of the embodiments herein may includeone or more fill indicators for the collection pathways and/or thecontainers on the devices so that users can know when sufficient filllevels have been reached.

Modular Sample Collection Device

Referring now to FIGS. 22A-22C, although the embodiments hereintypically describe sample collection device as having an adapter channelfor connecting the sample collection channels with the containers, itshould be understood that embodiments without such configurations arenot excluded.

By way of non-limiting example in FIG. 22A, as previously suggestedherein, some embodiments may be without a discrete, separate adapterchannel. Herein the collection channel 2422 may connect directly to thecontainer 2446 by way of relative motion between one or both of thoseelements as indicated by the arrow 2449.

By way of non-limiting example in FIG. 22B, one or more adapter channels2454 may be discrete elements not initially in direct fluidcommunication with either the collection channel 2422 or the containers2446. Herein the collection channel 2422 may connect to the container2446 by way of relative motion between one or more of the collectionchannel, the adapter channel(s) 2454, or the container 2446(sequentially or simultaneously) to create a fluid pathway from thecollection channels through the one or more adapter channels into thecontainers.

By way of non-limiting example in FIG. 22C, one or more adapter channels2454 may be elements initially in contact with the containers 2446. Theadapter channels 2454 may not be directly in communication with theinterior or the containers. Herein the collection channel 2400 mayconnect to the container by way of relative motion between one or moreof those elements (sequentially or simultaneously) to create a fluidpathway from the collection channels through the one or more adapterchannels into the containers. Some embodiments may have a septum,sleeve, sleeve with vent, or cover 2455 over the end of the collectionchannel which will be engaged by the adapter channel. The engagement ofthe various elements may also move the adapter channel 2454 into theinterior of the container 2446, as initially, the adapter channel 2454may not be in fluid communication with the interior. Some embodimentsherein may have more than adapter channel and some embodiments may useadapter channels with pointed ends on both ends of the channel. Theremay be variations and alternatives to the embodiments described hereinand that no single embodiment should be construed to encompass theentire invention.

It should be understood that any of the embodiments herein could bemodified to include the features recited in the description for FIGS.22A-22C.

Point of Service System

Referring now to FIG. 23, it should be understood that the processesdescribed herein may be performed using automated techniques. Theautomated processing may be used in an integrated, automated system. Insome embodiments, this may be in a single instrument having a pluralityof functional components therein and surrounded by a common housing. Theprocessing techniques and methods for sedimentation measure can bepre-set. Optionally, that may be based on protocols or procedures thatmay be dynamically changed as desired in the manner described in U.S.patent application Ser. Nos. 13/355,458 and 13/244,947, both fullyincorporated herein by reference for all purposes.

In one non-limiting example as shown in FIG. 23, an integratedinstrument 2500 may be provided with a programmable processor 2502 whichcan be used to control a plurality of components of the instrument. Forexample, in one embodiment, the processor 2502 may control a single ormultiple pipette system 2504 that is movable X-Y and Z directions asindicated by arrows 2506 and 2508. The same or different processor mayalso control other components 2512, 2514, or 2516 in the instrument. Inone embodiment, tone of the components 2512, 2514, or 2516 comprises acentrifuge.

As seen in FIG. 23, control by the processor 2502 may allow the pipettesystem 2504 to acquire blood sample from cartridge 2510 and move thesample to one of the components 2512, 2514, or 2516. Such movement mayinvolve dispensing the sample into a removable vessel in the cartridge2510 and then transporting the removable vessel to one of the components2512, 2514, or 2516. Optionally, blood sample is dispensed directly intoa container already mounted on one of the components 2512, 2514, or2516. In one non-limiting example, one of these components 2512, 2514,or 2516 may be a centrifuge with an imaging configuration to allow forboth illumination and visualization of sample in the container. Othercomponents 2512, 2514, or 2516 perform other analysis, assay, ordetection functions.

All of the foregoing may be integrated within a single housing 2520 andconfigured for bench top or small footprint floor mounting. In oneexample, a small footprint floor mounted system may occupy a floor areaof about 4 m² or less. In one example, a small footprint floor mountedsystem may occupy a floor area of about 3 m² or less. In one example, asmall footprint floor mounted system may occupy a floor area of about 2m² or less. In one example, a small footprint floor mounted system mayoccupy a floor area of about 1 m² or less. In some embodiments, theinstrument footprint may be less than or equal to about 4 m², 3 m², 2.5m², 2 m², 1.5 m², 1 m², 0.75 m², 0.5 m², 0.3 m², 0.2 m², 0.1 m², 0.08m², 0.05 m², 0.03 m², 100 cm², 80 cm², 70 cm², 60 cm², 50 cm², 40 cm²,30 cm², 20 cm², 15 cm², or 10 cm². Some suitable systems in apoint-of-service setting are described in U.S. patent application Ser.Nos. 13/355,458 and 13/244,947, both fully incorporated herein byreference for all purposes. The present embodiments may be configuredfor use with any of the modules or systems described in those patentapplications.

While the teachings has been described and illustrated with reference tocertain particular embodiments thereof, those skilled in the art willappreciate that various adaptations, changes, modifications,substitutions, deletions, or additions of procedures and protocols maybe made without departing from the spirit and scope of the invention.For example, with any of the above embodiments, it should be understoodthat the fluid sample may be whole blood, diluted blood, interstitialfluid, sample collected directly from the patient, sample that is on asurface, sample after some pre-treatment, or the like. Those of skill inthe art will understand that alternative embodiments may have more thanone container that may be sequentially operably coupled to the needle oropening of the channel to draw fluid in the container. Optionally, someembodiments may have the containers configured to operably couple to thechannels simultaneously. Some embodiments may integrate a lancing deviceor other wound creation device with the sample collection device tobring targeted sample fluid to a tissue surface and then collect thesample fluid, all using a single device. By way of nonlimiting example,a spring actuated, mechanically actuated, and/or electromechanicallyactuated tissue penetrating member may be mounted to have a penetratingtip exiting near an end of the sample collection device near samplecollection channel openings so that the wound site that is created willalso be along the same end of the device as the collection openings.Optionally, an integrated device may have collection openings on onesurface and tissue penetrating elements along another surface of thedevice. In any of the embodiments disclosed herein, the first opening ofthe collection channel may have a blunt shape, which is configured tonot readily puncture human skin.

Additionally, the use of heat patches on the finger or other targettissue can increase blood flow to the target area and thus increase thespeed with which sufficient blood or other bodily fluid can be drawnfrom the subject. The heating is used to bring the target tissue toabout 40 C to 50 C. Optionally, the heat brings target tissue to atemperature range of about 44 to 47 C.

Furthermore, those of skill in the art will recognize that any of theembodiments as described herein can be applied to collection of samplefluid from humans, animals, or other subjects. Some embodiments asdescribed herein may also be suitable for collection of non-biologicalfluid samples. Some embodiment may use containers that are not removablefrom the carrier. Some may have the fluid sample, after being metered inthe sample collection portion, be directed by the second motive force toa cartridge that is then placed into an analyte or other analysisdevice. Optionally, it should be understood although many embodimentsshow the containers in the carriers, embodiments where the containersare bare or not mounted in carrier are not excluded. Some embodimentsmay have the containers that are separate from the device and are onlybrought into fluid communication once the channels have reached minimumfill levels. For example, the containers may be held in a differentlocation and are only brought into contact by a technician oncesufficient amount of blood or sample fluid is in the sample collectiondevice. At that time, the containers may be brought into fluidcommunication simultaneously or sequentially to one or more of thechannels of the sample collection device.

Additionally, concentrations, amounts, and other numerical data may bepresented herein in a range format. It is to be understood that suchrange format is used merely for convenience and brevity and should beinterpreted flexibly to include not only the numerical values explicitlyrecited as the limits of the range, but also to include all theindividual numerical values or sub-ranges encompassed within that rangeas if each numerical value and sub-range is explicitly recited. Forexample, a size range of about 1 nm to about 200 nm should beinterpreted to include not only the explicitly recited limits of about 1nm and about 200 nm, but also to include individual sizes such as 2 nm,3 nm, 4 nm, and sub-ranges such as 10 nm to 50 nm, 20 nm to 100 nm, etc.. . .

The publications discussed or cited herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.All publications mentioned herein are incorporated herein by referenceto disclose and describe the structures and/or methods in connectionwith which the publications are cited. The following applications arefully incorporated herein by reference for all purposes: in U.S.Provisional Patent Application No. 61/435,250, filed Jan. 21, 2011(“SYSTEMS AND METHODS FOR SAMPLE USE MAXIMIZATION”), and U.S. PatentPublication No. 2009/0088336 (“MODULAR POINT-OF-CARE DEVICES, SYSTEMS,AND USES THEREOF”).

In one embodiment described herein, a device for collecting a bodilyfluid sample from a subject is provided comprising: at least two samplecollection pathways configured to draw the bodily fluid sample into thedevice from a single end of the device in contact with the subject,thereby separating the fluid sample into two separate samples; a secondportion comprising a plurality of sample containers for receiving thebodily fluid sample collected in the sample collection pathways, thesample containers operably engagable to be in fluid communication withthe sample collection pathways, whereupon when fluid communication isestablished, the containers provide a motive force to move a majority ofthe two separate samples from the pathways into the containers.

In another embodiment described herein, a device for collecting a bodilyfluid sample is provided comprising: a first portion comprising at leastone fluid collection location leading to at least two sample collectionpathways configured to draw the fluid sample therein via a first type ofmotive force; a second portion comprising a plurality of samplecontainers for receiving the bodily fluid sample collected in the samplecollection pathways, the sample containers operably engagable to be influid communication with the sample collection pathways, whereupon whenfluid communication is established, the containers provide a secondmotive force different from the first motive force to move a majority ofthe bodily fluid sample from the pathways into the containers; whereinat least one of the sample collection pathways comprises a fillindicator to indicate when a minimum fill level has been reached andthat at least one of the sample containers can be engaged to be in fluidcommunication with at least one of the sample collection pathways.

In another embodiment described herein, a device for collecting a bodilyfluid sample is provided comprising a first portion comprising at leasttwo sample collection channels configured to draw the fluid sample intothe sample collection channels via a first type of motive force, whereinone of the sample collection channels has an interior coating designedto mix with the fluid sample and another of the sample collectionchannels has another interior coating chemically different from saidinterior coating; a second portion comprising a plurality of samplecontainers for receiving the bodily fluid sample collected in the samplecollection channels, the sample containers operably engagable to be influid communication with the collection channels, whereupon when fluidcommunication is established, the containers provide a second motiveforce different from the first motive force to move a majority of thebodily fluid sample from the channels into the containers; whereincontainers are arranged such that mixing of the fluid sample between thecontainers does not occur.

In another embodiment described herein, a device for collecting a bodilyfluid sample is provided comprising: a first portion comprising aplurality of sample collection channels, wherein at least two of thechannels are configured to simultaneously draw the fluid sample intoeach of the at least two sample collection channels via a first type ofmotive force; a second portion comprising a plurality of samplecontainers for receiving the bodily fluid sample collected in the samplecollection channels, wherein the sample containers have a firstcondition where the sample containers are not in fluid communicationwith the sample collection channels, and a second condition where thesample containers are operably engagable to be in fluid communicationwith the collection channels, whereupon when fluid communication isestablished, the containers provide a second motive force different fromthe first motive force to move bodily fluid sample from the channelsinto the containers.

In another embodiment described herein, a sample collection device isprovided comprising: (a) a collection channel comprising a first openingand a second opening, and being configured to draw a bodily fluid samplevia capillary action from the first opening towards the second opening;and (b) a sample container for receiving the bodily fluid sample, thecontainer being engagable with the collection channel, having aninterior with a vacuum therein, and having a cap configured to receive achannel; wherein the second opening is defined by a portion thecollection channel configured to penetrate the cap of the samplecontainer, and to provide a fluid flow path between the collectionchannel and the sample container, and the sample container has aninterior volume no greater than ten times larger than the interiorvolume of the collection channel.

In another embodiment described herein, a sample collection device isprovided comprising: (a) a collection channel comprising a first openingand a second opening, and being configured to draw a bodily fluid samplevia capillary action from the first opening towards the second opening;(b) a sample container for receiving the bodily fluid sample, thecontainer being engageable with the collection channel, having aninterior with a vacuum therein, and having a cap configured to receive achannel; and (c) an adaptor channel configured to provide a fluid flowpath between the collection channel and the sample container, having afirst opening and a second opening, the first opening being configuredto contact the second opening of the collection channel, the secondopening being configured to penetrate the cap of the sample container.

In another embodiment described herein, a sample collection device isprovided comprising: (a) a body, containing a collection channel, thecollection channel comprising a first opening and a second opening, andbeing configured to draw a bodily fluid via capillary action from thefirst opening towards the second opening; (b) a base, containing asample container for receiving the bodily fluid sample, the samplecontainer being engageable with the collection channel, having aninterior with a vacuum therein, and having a cap configured to receive achannel; and (c) a support, wherein, the body and the base are connectedto opposite ends of the support, and are configured to be movablerelative to each other, such that sample collection device is configuredto have an extended state and a compressed state, wherein at least aportion of the base is closer to the body in the extended state of thedevice than in the compressed state, the second opening of thecollection channel is configured to penetrate the cap of the samplecontainer, in the extended state of the device, the second opening ofthe collection channel is not in contact with the interior of the samplecontainer, and in the compressed state of the device, the second openingof the collection channel extends into the interior of the samplecontainer through the cap of the container, thereby providing fluidiccommunication between the collection channel and the sample container.

In another embodiment described herein, a sample collection device isprovided comprising: (a) a body, containing a collection channel, thecollection channel comprising a first opening and a second opening, andbeing configured to draw a bodily fluid via capillary action from thefirst opening towards the second opening; (b) a base, containing asample container for receiving the bodily fluid sample, the samplecontainer being engageable with the collection channel, having aninterior with a vacuum therein and having a cap configured to receive achannel; (c) a support, and (d) an adaptor channel, having a firstopening and a second opening, the first opening being configured tocontact the second opening of the collection channel, and the secondopening being configured to penetrate the cap of the sample container,wherein, the body and the base are connected to opposite ends of thesupport, and are configured to be movable relative to each other, suchthat sample collection device is configured to have an extended stateand a compressed state, wherein at least a portion of the base is closerto the body in the extended state of the device than in the compressedstate, in the extended state of the device, the adaptor channel is notin contact with one or both of the collection channel and the interiorof the sample container, and in the compressed state of the device, thefirst opening of the adaptor channel is in contact with the secondopening of the collection channel, and the second opening of the adaptorchannel extends into the interior of the sample container through thecap of the container, thereby providing fluidic communication betweenthe collection channel and the sample container.

In another embodiment described herein, a device for collecting a fluidsample from a subject is provided comprising: (a) a body containing acollection channel, the collection channel comprising a first openingand a second opening, and being configured to draw a bodily fluid viacapillary action from the first opening towards the second opening; (b)a base, engageable with the body, wherein the base supports a samplecontainer, the container being engageable with the collection channel,having an interior with a vacuum therein, and having a cap configured toreceive a channel; wherein the second opening of the collection channelis configured to penetrate the cap of the sample container, and toprovide a fluid flow path between the collection channel and the samplecontainer.

In another embodiment described herein, a device for collecting a fluidsample from a subject is provided comprising: (a) a body containing acollection channel, the collection channel comprising a first openingand a second opening, and being configured to draw a bodily fluid viacapillary action from the first opening towards the second opening; (b)a base, engagable with the body, wherein the base supports a samplecontainer, the sample container being engageable with the collectionchannel, having an interior with a vacuum therein and having a capconfigured to receive a channel; and (c) an adaptor channel, having afirst opening and a second opening, the first opening being configuredto contact the second opening of the collection channel, and the secondopening being configured to penetrate the cap of the sample container.

It should be understood that one or more of the following features maybe adapted for use with any of the embodiments described herein. By wayof non-limiting example, the body may comprise of two collectionchannels. Optionally, the interior of the collection channel(s) arecoated with an anticoagulant. Optionally, the body comprises a firstcollection channel and a second collection channel, and the interior ofthe first collection channel is coated with a different anticoagulantthan the interior of the second collection channel. Optionally, thefirst anticoagulant is ethylenediaminetetraacetic acid (EDTA) and thesecond anticoagulant is different from EDTA. Optionally, the firstanticoagulant is citrate and the second anticoagulant is different fromcitrate. Optionally, the first anticoagulant is heparin and the secondanticoagulant is different from heparin. Optionally, one anticoagulantis heparin and the second anticoagulant is EDTA. Optionally, oneanticoagulant is heparin and the second anticoagulant is citrate.Optionally, one anticoagulant is citrate and the second anticoagulant isEDTA. Optionally, the body is formed from an optically transmissivematerial. Optionally, the device includes the same number of samplecontainers as collection channels. Optionally, the device includes thesame number of adaptor channels as collection channels. Optionally, thebase contains an optical indicator that provides a visual indication ofwhether the sample has reached the sample container in the base.Optionally, the base is a window that allows a user to see the containerin the base. Optionally, the support comprises a spring, and springexerts a force so that the device is at the extended state when thedevice is at its natural state. Optionally, the second opening of thecollection channel or the adaptor channel is capped by a sleeve, whereinsaid sleeve does not prevent movement of bodily fluid via capillaryaction from the first opening towards the second opening. Optionally,the sleeve contains a vent. Optionally, each collection channel can holda volume of no greater than 500 uL. Optionally, each collection channelcan hold a volume of no greater than 200 uL. Optionally, each collectionchannel can hold a volume of no greater than 100 uL. Optionally, eachcollection channel can hold a volume of no greater than 70 uL.Optionally, each collection channel can hold a volume of no greater than500 uL. Optionally, each collection channel can hold a volume of nogreater than 30 uL. Optionally, the internal circumferential perimeterof a cross-section of each collection channel is no greater than 16 mm.Optionally, the internal circumferential perimeter of a cross-section ofeach collection channel is no greater than 8 mm. Optionally, theinternal circumferential perimeter of a cross-section of each collectionchannel is no greater than 4 mm. Optionally, the internalcircumferential perimeter is a circumference. Optionally, the devicecomprises a first and a second collection channel, and the opening ofthe first channel is adjacent to an opening of said second channel, andthe openings are configured to draw blood simultaneously from a singledrop of blood. Optionally, the opening of the first channel and theopening of the second channel have a center-to-center spacing of lessthan or equal to about 5 mm. Optionally, each sample container has aninterior volume no greater than twenty times larger than the interiorvolume of the collection channel with which it is engagable. Optionally,each sample container has an interior volume no greater than ten timeslarger than the interior volume of the collection channel with which itis engagable. Optionally, each sample container has an interior volumeno greater than five times larger than the interior volume of thecollection channel with which it is engagable. Optionally, each samplecontainer has an interior volume no greater than two times larger thanthe interior volume of the collection channel with which it isengagable. Optionally, establishment of fluidic communication betweenthe collection channel and the sample container results in transfer ofat least 90% of the bodily fluid sample in the collection channel intothe sample container.

It should be understood that one or more of the following features maybe adapted for use with any of the embodiments described herein.Optionally, establishment of fluidic communication between thecollection channel and the sample container results in transfer of atleast 95% of the bodily fluid sample in the collection channel into thesample container. Optionally, establishment of fluidic communicationbetween of the collection channel and the sample container results intransfer of at least 98% of the bodily fluid sample in the collectionchannel into the sample container. Optionally, establishment of fluidiccommunication between the collection channel and the sample containerresults in transfer of the bodily fluid sample into the sample containerand in no more than ten uL of bodily fluid sample remaining in thecollection channel. Optionally, establishment of fluidic communicationbetween the collection channel and the sample container results intransfer of the bodily fluid sample into the sample container and in nomore than five uL of bodily fluid sample remaining in the collectionchannel. Optionally, engagement of the collection channel with thesample container results in transfer of the bodily fluid sample into thesample container and in no more than 2 uL of bodily fluid sampleremaining in the collection channel.

In another embodiment described herein, a method is provided comprisingcontacting one end of a sample collection device to a bodily fluidsample to split the sample into at least two portions by drawing thesample into at least two collection channels of the sample collectiondevice by way of a first type of motive force; establishing fluidcommunication between the sample collection channels and the samplecontainers after a desired amount of sample fluid has been confirmed tobe in at least one of the collection channels, whereupon the containersprovide a second motive force different from the first motive force tomove each of the portions of bodily fluid sample into their respectivecontainers.

In another embodiment described herein, a method is provided comprisingmetering a minimum amount of sample into at least two channels by usinga sample collection device with at least two of the sample collectionchannels configured to simultaneously draw the fluid sample into each ofthe at least two sample collection channels via a first type of motiveforce; after a desired amount of sample fluid has been confirmed to bein the collection channels, fluid communication is established betweenthe sample collection channels and the sample containers, whereupon thecontainers provide a second motive force different from the first motiveforce use to collect the samples to move bodily fluid sample from thechannels into the containers.

In another embodiment described herein, a method of collecting a bodilyfluid sample is provided comprising (a) contacting a bodily fluid samplewith a device comprising a collection channel, the collection channelcomprising a first opening and a second opening, and being configured todraw a bodily fluid via capillary action from the first opening towardsthe second opening, such that the bodily fluid sample fills thecollection channel from the first opening through the second opening;(b) establishing a fluid flow path between the collection channel andthe interior of a sample container, said sample container having aninterior volume no greater than ten times larger than the interiorvolume of the collection channel and having a vacuum prior toestablishment of the fluid flow path between the collection channel andthe interior of the sample container, such that establishment of thefluid flow path between the collection channel and the interior of thesample container generates a negative pressure at the second opening ofthe collection channel, and the fluidic sample is transferred from thecollection channel to the interior of the sample container.

In another embodiment described herein, a method of collecting a bodilyfluid sample is provided comprising (a) contacting a bodily fluid samplewith any collection device as described herein, such that the bodilyfluid sample fills the collection channel from the first opening throughthe second opening of at least one of the collection channel(s) in thedevice; and (b) establishing a fluid flow path between the collectionchannel and the interior of the sample container, such that establishinga fluid flow path between the collection channel and the interior of thesample container generates a negative pressure at the second opening ofthe collection channel, and the fluidic sample is transferred from thecollection channel to the interior of the sample container.

It should be understood that one or more of the following features maybe adapted for use with any of the embodiments described herein.Optionally, the collection channel and the interior of the samplecontainer are not brought into fluid communication until the bodilyfluid reaches the second opening of the collection channel. Optionally,the device comprises two collection channels, and the collectionchannels and the interior of the sample containers are not brought intofluidic communication until the bodily fluid reaches the second openingof both collection channels. Optionally, the second opening of thecollection channel in the device is configured to penetrate the cap ofthe sample container, and wherein a fluidic flow path between the secondopening of the collection channel and the sample container isestablished by providing relative movement between the second opening ofthe collection channel and the sample container, such that the secondopening of the collection channel penetrates the cap of the samplecontainer. Optionally, the device comprises an adaptor channel for eachcollection channel in the device, the adaptor channel having a firstopening and a second opening, the first opening being configured tocontact the second opening of the collection channel, and the secondopening being configured to penetrate the cap of the sample container,and wherein a fluidic flow path between the collection channel and thesample container is established by providing relative movement betweentwo or more of: (a) the second opening of the collection channel, (b)the adaptor channel, and (c) the sample container, such that the secondopening of the adaptor channel penetrates the cap of the samplecontainer.

In another embodiment described herein, a method for collecting a bodilyfluid sample from a subject is provided comprising: (a) bringing adevice comprising a first channel and a second channel into fluidiccommunication with a bodily fluid from the subject, each channel havingan input opening configured for fluidic communication with said bodilyfluid, each channel having an output opening downstream of the inputopening of each channel, and each channel being configured to draw abodily fluid via capillary action from the input opening towards theoutput opening; (b) bringing, through the output opening of each of thefirst channel and the second channel, said first channel and said secondchannel into fluidic communication with a first container and a secondcontainer, respectively; and (c) directing said bodily fluid within eachof said first channel and second channel to each of said first containerand second container with the aid of: (i) negative pressure relative toambient pressure in said first container or said second container,wherein said negative pressure is sufficient to effect flow of saidbodily fluid through said first channel or said second channel into itscorresponding container, or (ii) positive pressure relative to ambientpressure upstream of said first channel or said second channel, whereinsaid positive pressure is sufficient to effect flow of said whole bloodsample through said first channel or said second channel into itscorresponding container.

In another embodiment described herein, a method of manufacturing asample collection device is provided comprising forming one portion of asample collection device having at least two channels configured tosimultaneously draw the fluid sample into each of the at least twosample collection channels via a first type of motive force; formingsample containers, whereupon the containers are configured to be coupledto the sample collection device to the provide a second motive forcedifferent from the first motive force use to collect the samples to movebodily fluid sample from the channels into the containers.

In another embodiment described herein, computer executable instructionsare provided for performing a method comprising: forming one portion ofa sample collection device having at least two channels configured tosimultaneously draw the fluid sample into each of the at least twosample collection channels via a first type of motive force.

In another embodiment described herein, computer executable instructionsfor performing a method comprising: forming sample containers, whereuponthe containers are configured to be coupled to the sample collectiondevice to provide a second motive force different from the first motiveforce use to collect the samples to move bodily fluid sample from thechannels into the containers.

In yet another embodiment described herein, a device for collecting abodily fluid sample from a subject, the device comprising: means fordrawing the bodily fluid sample into the device from a single end of thedevice in contact with the subject, thereby separating the fluid sampleinto two separate samples; means for transferring the fluid sample intoa plurality of sample containers, wherein the containers provide amotive force to move a majority of the two separate samples from thepathways into the containers.

While the above is a complete description of the preferred embodiment asdescribed herein, it is possible to use various alternatives,modifications and equivalents. Therefore, the scope of the presentinvention should be determined not with reference to the abovedescription but should, instead, be determined with reference to theappended claims, along with their full scope of equivalents. Anyfeature, whether preferred or not, may be combined with any otherfeature, whether preferred or not. The appended claims are not to beinterpreted as including means-plus-function limitations, unless such alimitation is explicitly recited in a given claim using the phrase“means for.” It should be understood that as used in the descriptionherein and throughout the claims that follow, the meaning of “a,” “an,”and “the” includes plural reference unless the context clearly dictatesotherwise. Also, as used in the description herein and throughout theclaims that follow, the meaning of “in” includes “in” and “on” unlessthe context clearly dictates otherwise. Finally, as used in thedescription herein and throughout the claims that follow, the meaningsof “and” and “or” include both the conjunctive and disjunctive and maybe used interchangeably unless the context expressly dictates otherwise.Thus, in contexts where the terms “and” or “or” are used, usage of suchconjunctions do not exclude an “and/or” meaning unless the contextexpressly dictates otherwise.

This document contains material subject to copyright protection. Thecopyright owner (Applicant herein) has no objection to facsimilereproduction of the patent documents and disclosures, as they appear inthe US Patent and Trademark Office patent file or records, but otherwisereserves all copyright rights whatsoever. The following notice shallapply: Copyright 2012 Theranos, Inc.

1-55. (canceled)
 56. A device for collecting a fluid sample from asubject, comprising: (a) a body containing at least a portion of atleast one collection channel, the collection channel comprising a firstopening and a second opening, and being configured to draw a bodilyfluid via capillary action from the first opening towards the secondopening; (b) at least one adaptor channel having a first opening and asecond opening, the first opening aligned with the second opening of thecollection channel, and the adaptor channel being configured topenetrate a cap of the sample container; and (c) at least one samplecontainer movable between a first position on the device and a secondposition on the device to engage the adaptor channel.
 57. The device ofclaim 56 wherein the body comprises at least two collection channels.58. The device of claim 56 wherein an interior of the collection channelis coated with an anticoagulant.
 59. The device of claim 57, wherein aninterior of a first of the collection channels is coated with a firstanticoagulant different from a second anticoagulant coating an interiorof a second of the collection channels.
 60. The device of claim 59,wherein the first anticoagulant is ethylenediaminetetraacetic acid(EDTA) and the second anticoagulant is different from EDTA.
 61. Thedevice of claim 59, wherein the first anticoagulant is citrate and thesecond anticoagulant is different from citrate.
 62. The device of claim59, wherein the first anticoagulant is heparin and the secondanticoagulant is different from heparin.
 63. The device of claim 56,wherein the body is formed from an optically transmissive material. 64.The device of claim 56 wherein the number of sample containers is thesame as the number of collection channels.
 65. The device of claim 56further comprising a base coupled to the body, wherein the basecomprises an optical indicator that provides a visual indication ofwhether the sample has reached the sample container in the base.
 66. Thedevice of claim 65, wherein the base is a window that allows a user tosee the container in the base.
 67. The device of claim 56, wherein thesecond opening of the collection channel or the adaptor channel iscapped by a sleeve, wherein said sleeve does not prevent movement ofbodily fluid via capillary action from the first opening towards thesecond opening.
 68. The device of claim 56, wherein each collectionchannel can hold a volume of no greater than 200 uL.
 69. The device ofclaim 56, wherein each collection channel can hold a volume of nogreater than 100 uL.
 70. The device of claim 57, wherein an opening ofthe first channel is adjacent to an opening of said second channel, andthe openings are configured to draw blood simultaneously from the fluidsample.
 71. The device of claim 70, wherein the opening of the firstchannel and the opening of the second channel have a center-to-centerspacing of less than or equal to about 5 mm.
 72. The device of claim 56,wherein each sample container has an interior volume no greater than twotimes larger than the interior volume of the collection channel withwhich it is engagable.
 73. The device of claim 56, wherein establishmentof fluidic communication between the collection channel and the samplecontainer results in transfer of at least 90% of the bodily fluid samplein the collection channel into the sample container.
 74. The device ofclaim 56, wherein the sample container provides a motive force differentfrom capillary action to move fluid sample into the sample containerwhen the sample container is in fluid communication with the adaptorchannel.
 75. The device of claim 56 further comprising an fluid flowmechanism that provides a motive force different from capillary actionto move fluid sample from the collection channel into the samplecontainer when the sample container is in fluid communication with theadaptor channel.